30 results
Page of 3
  • A Multi-Institutional Registry for CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) - NCT02457117

    To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI. View All Details

    • Protocol Number:
      041902

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

      • Contacts:

      • RWJBarnabas Health - Community Medical Center Prinicipal Investigator: David D'Ambrosio

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Subjects are eligible to participate in the registry if they receive CK-SAPBI in 5 fractions within 12 weeks of surgery and sign an institution specific consent form. Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:
    • Newly diagnosed AJCC (seventh edition) Stage 0 or I breast cancer.
    • On histological examination, the tumor must be DCIS or invasive non-lobular carcinoma of the breast
    • Surgical treatment of the breast must have been wide excision, lumpectomy or partial mastectomy
    • Age 50 years or greater
    • ER positive
    • PR positive
    • Her2 negative (IHC 0-1+; for IHC 2+, FISH must be non-amplified)
    • Subjects with invasive tumors should undergo axillary sentinel lymph node evaluation or axillary lymph node dissection.
    • Negative inked surgical margins of excision or re-excision, clear of invasive tumor and DCIS by at least 2 mm
    • Negative post-excision or post-reexcision mammography if cancer presented with malignancy-associated microcalcifications with no remaining suspicious calcifications in the breast before radiotherapy. Alternatively, a specimen radiograph can be obtained showing all the suspicious calcifications.
    • No involved axillary lymph nodes, N0(i+) allowed
    • Target lumpectomy cavity/whole breast reference volume must be <30% based on treatment planning CT

    Exclusion Criteria:

    • -Patients with invasive lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
    • Patients with tumors greater than 2 cm
    • Patients with surgical margins which cannot be microscopically assessed or not cleared by at least 2mm at pathological evaluation.
    • Patients with multicentric carcinoma or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy. Breast MRI will be required to exclude multicentric disease and additional suspicious areas will require biopsy to exclude malignancy.
    • Patients with involved axillary nodes.
    • Patients with collagen vascular diseases (active).
    • Patient with known deleterious BRCA1/2 mutations or known mutations in other high penetrance genes (TP53, STK11, PTEN, CDH1)
    • Patients with prior ipsilateral breast irradiation.
    • Patients with prior ipsilateral thoracic irradiation.
    • Patients with Paget's disease of the nipple.
    • Patients with diffuse suspicious microcalcifications.
    • Patients with suspicious microcalcifications remaining on the post-excision mammogram.
    • Patients receiving (neo)adjuvant systemic therapy other than hormonal therapy
    • Patients with oncoplastic reconstruction and absence of surgical clips

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Community Medical Center
  • A Multicenter Phase II Study of Vaccines to Prevent Recurrence in Patients with HER-2 Positive Breast Cancer. - NCT03384914

    Primary Objectives - To evaluate safety and tolerability of each vaccine therapy - To determine disease free survival (DFS) of patients with HER2 positive breast cancer after treatment with each vaccine Secondary Objectives - To evaluate the immunogenicity following each vaccine therapy View All Details

    • Protocol Number:
      041807

    • Principal Investigator:
      Maria Kowzun

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast - Female,Breast - Male

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      WOKVAC DC1VAC

      • Contacts:

      • Rutgers University Prinicipal Investigator: Maria Kowzun

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Clinical stage I-III HER2 positive breast cancer treated with neoadjuvant chemotherapy including HER-2 directed treatment for at least 12 weeks.
    • Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy.
    • Completed last cycle of cytotoxic chemotherapy (excluding ado-trastuzumab emtansine [T-DM1]) or radiation > 30 days with resolution of all acute toxic effects of prior therapy to grade ≤ 2 (except alopecia)
    • Currently on HER-2 targeted therapy (eg; trastuzumab +/- pertuzumab or T-DM1) per standard of care or has completed HER-2 targeted therapy less than 6 months ago
    • Age ≥ 18 years.
    • Eastern Cooperative Group (ECOG) performance status 0 or 1.
    • Must have normal organ and marrow function as defined below:
    • Absolute neutrophil count (ANC) ≥ 1,000/ μL
    • Platelets ≥ 75,000/ μL
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be <3.0 mg/dL
    • AST/ALT ≤ 3 x institutional upper limit of normal (ULN)
    • Creatinine ≤ 1.5 x institutional upper limit of normal (ULN)
    • Hemoglobin A1C <6.5%
    • Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or MUGA scan within 90 days of registration).
    • Females of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and males must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. For both male and female participants, effective methods of contraception must be used throughout the study and for three months following the last dose.
    • Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures.

    Exclusion Criteria:

    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congenital prolonged QT syndrome, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Uncontrolled autoimmune disease requiring active systemic treatment.
    • Known hypersensitivity reaction to the Granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF.
    • Pregnant or breast feeding.
    • Known HIV-positive.
    • Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared.
    • Major surgery within 4 weeks of initiation of study drug.
    • Current extended use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. A brief course of corticosteroids for prophylaxis (eg., for contrast dye allergy) or for treatment of non-autoimmune conditions (eg., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
    • Potential participant is currently on active treatment in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Multicenter, Open-Label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors(LEAP-005) - NCT03797326

    Primary Objectives: (1) To evaluate objective response rate (ORR) of pembrolizumab in combination with lenvatinib per tumor cohort based on RECIST 1.1 by investigator assessments in initial cohorts and BICR in cohorts that expand combining the initial and expansion cohorts. (For participants with GBM, response will be assessed based on Response Assessment in Neuro-Oncology (RANO) criteria; all further references to RECIST 1.1 assessment apply to all cohorts except GBM). (2) To assess safety and tolerability of treatment with pembrolizumab in combination with lenvatinib per tumor cohort assessed by the proportion of AEs. Secondary Objectives: (1) To evaluate disease control rate (DCR), duration of response (DOR) and progression-free survival (PFS) of pembrolizumab in combination with lenvatinib per tumor cohort based on RECIST 1.1 by investigator assessments in initial cohorts and BICR in cohorts that expand combining the initial and expansion cohorts. (2) To evaluate overall survival (OS) of pembrolizumab in combination with lenvatinib per tumor cohort. (3) To characterize the population pharmacokinetics (PK) of lenvatinib when coadministered with pembrolizumab in participants per tumor cohort. View All Details

    • Protocol Number:
      051902

    • Principal Investigator:
      Kristen Spencer DO, MPH

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Ovary,Other Digestive Organ,Brain and Nervous System,Breast,Stomach,Colon

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pembrolizumab (MK-3475) Lenvatinib (E7080/MK-7902)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Kristen Spencer DO, MPH

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
    • Must have progressed on or since the last treatment
    • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
    • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
    • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
    • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
    • Has adequate organ function For Triple Negative Breast Cancer Participants:
    • Has received one or 2 prior lines of therapy
    • Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
    • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses For Ovarian Cancer Participants:
    • Has primary ovarian cancer and has received 3 prior lines of therapy. For Gastric Cancer Participants:
    • Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible For Colorectal Cancer Participants:
    • Has received 2 prior lines of therapy For GBM Participants:
    • Has failed initial systemic therapy for newly diagnosed GBM
    • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
    • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
    • Has histologically confirmed World Health Organization (WHO) Grade IV GBM
    • Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis For Biliary Tract Cancer Participants:
    • Has received 1 prior line of therapy
    • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6 For Pancreatic Cancer Participants:
    • Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
    • Has received one or 2 prior lines of therapy
    • Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer

    Exclusion Criteria:

    • Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
    • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
    • Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
    • Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
    • Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
    • Has a history of arterial thromboembolism within 12 months of start of study treatment
    • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • Has a serious nonhealing wound, ulcer or bone fracture
    • Has had major surgery within 3 weeks prior to first dose of study interventions
    • Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
    • Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
    • Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
    • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
    • If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
    • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
    • Has received a live vaccine within 30 days prior to the first dose of study treatment
    • Has known intolerance to lenvatinib (and/or any of the excipients)
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
    • Has known active CNS metastases and/or carcinomatous meningitis
    • Has tumors involving the brain stem
    • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
    • Has an active autoimmune disease that has required systemic treatment in past 2 years
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection
    • Has a known history of hepatitis B or known active hepatitis C virus infection
    • Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
    • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
    • Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection) For GBM Participants:
    • Has carcinomatous meningitis
    • Has recurrent tumor greater than 6 cm in maximum diameter
    • Has tumor primarily localized to the brainstem or spinal cord
    • Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
    • Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
    • Has received Optune® TTFields within 2 weeks of study intervention

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients - NCT04871516

    The current standard of care for patients with invasive non-metastatic breast cancer who are candidates for Breast Conserving Surgery (BCS) is adjuvant whole breast radiation followed by an additional boost to the tumor bed. The benefit of tumor bed boost in reducing the local recurrence rates is established from historic clinical trials. However, the sequential delivery of the boost after surgery and radiation is done out of convention rather than any particular scientific rationale. Delivering the boost in the pre-operative setting provides the benefit of accurately directing the high radiation dose at the tumor and thus sparing normal breast tissue. It also takes advantage of a non-hypoxic microenvironment leading to an increase in the therapeutic ratio and superior outcome. We hypothesize that delivering the radiation boost pre-operatively will not result in a significantly higher risk of surgical wound complications. We also think that this approach will result in better cosmesis and less radiation toxicity to normal tissue. This is a prospective phase II single arm clinical trial evaluating the feasibility of delivering the breast radiation boost pre-operatively in non-metastatic, node negative breast cancer patients who are eligible for breast conserving surgery. Our primary objective is to measure the incidence of grade 3 or more wound complications at 1 month after surgery in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery and who get treated on protocol with a pre-operative boost. Secondary and tertiary objectives are: - to measure the rate of poor/fair cosmetic outcome as assessed by physicians at 1 year and 3 years after completion of radiation. - to measure patient reported cosmetic outcomes - to measure the incidence of acute and late radiation toxicity - to assess tumor pathophysiology before and after treatment - to measure the difference in the irradiated volume if a post-operative boost plan were to be done. View All Details

    • Protocol Number:
      042005

    • Principal Investigator:
      Bruce Haffty MD

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Radiotherapy

      • Contacts:

      • Rutgers University Prinicipal Investigator: Bruce Haffty MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Breast cancer patients with biopsy proven invasive cancer
    • Clinically and radiographically node negative
    • No indication of metastatic disease
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
    • Synchronous bilateral invasive cancer allowed
    • Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
    • Willingness to participate in the clinical trial and adhere to the study protocol
    • Individuals of all races, genders and ethnic groups are eligible for this trial

    Exclusion Criteria:

    • Need for neoadjuvant chemotherapy
    • Inflammatory breast cancer (cT4)
    • Multicentric tumor
    • Prior ipsilateral breast or thoracic RT
    • Contraindication for baseline magnetic resonance imaging (MRI)
    • Contraindication for surgery
    • Distant metastatic disease
    • Other synchronous cancer (besides bilateral breast)
    • Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
    • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A Phase II Study of U3-1402 in Patients with Metastatic Breast Cancer. - NCT04699630

    Primary Objective: To evaluate overall response rate (ORR) and progression-free survival at 6 months (PFS-6) of single agent U3-1402 in patients with metastatic breast cancer (MBC). Secondary Objectives: 1. To assess the safety and tolerability of U3-1402 in patients with MBC. 2. To estimate the duration of response (DoR) and PFS in patients with MBC. View All Details

    • Protocol Number:
      042103

    • Principal Investigator:
      Deborah Toppmeyer M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      U3-1402

      • Contacts:

      • Rutgers University Prinicipal Investigator: Deborah Toppmeyer M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Patients must meet the following criteria in order to be included in the research study: 1. Written informed consent, according to local guidelines, signed and dated by the patient or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses 2. Women and men at least 18 years-of-age at the time of signature of the informed consent form (ICF) 3. Histologically documented locally advanced or metastatic breast cancer 4. Triple-negative breast cancer patients should have received at least 1 but no more than 3 prior lines of chemotherapy in the metastatic setting 5. HR+ breast cancer patients should have received prior treatment with endocrine therapy +CDK 4/6 inhibitor. No limit to prior endocrine therapy regimens but no more than 2 prior chemotherapy regimens in the metastatic setting 6. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (bone-only disease excluded) 7. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed ≥4 weeks prior to initiation of study treatment (2 weeks for patients who received palliative radiation therapy), there is no evidence of central nervous system disease progression on a scan or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy for the treatment of brain metastases 8. Willingness to undergo pre-treatment biopsy and on-treatment biopsies. Must have a tumor amenable to pre-treatment biopsy (unless archived tissue is available and was obtained within 2 months prior to starting treatment) and on-treatment biopsy (excludes bone lesions and previously irradiated lesions). 9. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 10. Has adequate organ function within 7 days before the start of study treatment, defined as:
    • Platelet count ≥100 × 109/L
    • Hemoglobin (Hb) ≥9 g/dL (transfusion and/or growth factor support allowed)
    • Absolute neutrophil count ≥1.5 × 109/L
    • Prothrombin time (PT) and partial thromboplastin time (PTT) ≤1.5 × the upper limit of normal (ULN), except for patients on coumadin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-international normalized ratio (INR) within therapeutic range as deemed appropriate by the Investigator.
    • Serum creatinine ≤1.5 × ULN, or creatinine clearance ≥ 50 mL/min as calculated using the modified Cockcroft-Gault equation; confirmation of creatinine clearance is only required when creatinine is >1.5 × ULN.
    • AST/ALT ≤3 × ULN (if liver metastases are present, ≤5 × ULN)
    • Total bilirubin ≤1.5 × ULN if no liver metastases or < 3 × ULN in the presence of documented Gilbert's syndrome or liver metastases
    • Serum albumin ≥ 2.5 g/dL 11. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for at least 7 months following last dose. Male patients must also refrain from donating sperm during their participation in the study.

    Exclusion Criteria:

      Patients who meet any of the following criteria will be excluded from study entry: 1. Treatment with any of the following:
    • Any systemic anti-cancer chemotherapy, small molecule, biologic, hormonal agent, or immune checkpoint inhibitor therapy from a previous treatment regimen or clinical study within 21 days prior to the first dose of U3-1402.
    • Prior treatment with any HER3 targeting agent
    • Prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201a, DS-1062a, and DS-7300a)
    • Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug treatment
    • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug treatment, or palliative radiation therapy within 2 weeks of the first dose of study drug treatment
    • Chloroquine /hydroxychloroquine ≤14 days prior to the first dose of study drug treatment. 2. Patients with HER2-positive breast cancer per ASCO-CAP guidelines 3. Has any hypersensitivity to drug substances or inactive ingredients in drug product. 4. Has any history of ILD (including pulmonary fibrosis or radiation pneumonitis), has clinically significant ILD, or is suspected to have such disease by imaging during screening. If imaging findings are unlikely to indicate a history of pneumonitis, then the Investigator should discuss the considerations with the Medical Monitor about potential enrollment and record the reasoning in the source documentation. 5. Clinically severe pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to: 1. any underlying pulmonary disorder (e.g., pulmonary emboli, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) 2. any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis) OR prior pneumonectomy 6. With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or baseline at the time of starting study treatment. Note: patients with chronic Grade 2 toxicities who are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor. 7. Leptomeningeal metastases or spinal cord compression due to disease 8. Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 7 months after the last administration of study treatment 9. Men who plan to father a child while in the study and for at least 7 months after the last administration of study treatment 10. Any of the following cardiac criteria currently or within the last 6 months:
    • Mean resting corrected QT interval using Fridericia's formula (QTcF) prolongation to >470 ms for females and >450 ms for males in three successive screening measurements
    • Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third-degree heart block
    • Congestive heart failure (New York Heart Association ≥ Grade 2 [Appendix D])
    • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
    • Patients with a left ventricular ejection fraction (LVEF) <50% 11. Has known clinically significant corneal disease from prior therapies such as drug-induced keratitis 12. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required. 13. Presence of other active invasive cancers other than the one treated in this study within 3 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment 14. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Randomized, Multicenter, Double-Blind Phase 3 Study of SAR439859 Plus Palbociclib versus Letrozole plus Palbociclib for the Treatment of Patients with ER (+), HER2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti-Cancer Treatment for Advanced Disease. - NCT04478266

    Primary: - To determine whether SAR439859 in combination with palbociclib improves PFS when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease Secondary: - To compare the overall survival in both treatment arms. - To evaluate the ORR in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the CBR in both treatment arms. - To evaluate PK of SAR439859, goserelin and palbociclib. - To evaluate HRQL in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms. View All Details

    • Protocol Number:
      042013

    • Principal Investigator:
      Coral Omene MD, PhD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Palbociclib LETROZOLE SAR439859

      • Contacts:

      • Rutgers University Prinicipal Investigator: Coral Omene MD, PhD

    Read Inclusion & Exclusion Criteria

    Inclusion criteria :

    • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
    • Confirmed diagnosis of ER+/HER2- breast cancer
    • No prior systemic treatment for loco-regional recurrent or metastatic disease
    • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • Participants should be willing to provide tumor tissue
    • Capable of giving informed consent Exclusion criteria:
    • Known active brain metastases
    • Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
    • Inadequate organ and marrow function
    • Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
    • Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
    • Male participants who disagree to follow contraception
    • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
    • Participants with significant concomitant illness The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy. - NCT01901094

    Primary Objective: - To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy. 2.2 Secondary Objectives: 2.2.1 To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy. 2.2.2 For each Treatment Arm: - To obtain an estimate of the distribution of residual disease burden scores. - To estimate the distribution of overall survival. 2.3 Correlative Objectives - To estimate the incidence of arm lymphedema. - To estimate the incidence of breast lymphedema for patients who underwent breast conserving surgery based on the specific treatment rendered to the axilla. View All Details

    • Protocol Number:
      041502

    • Principal Investigator:
      Bruce Haffty MD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast - Female

      • Contacts:

      • Rutgers University Prinicipal Investigator: Bruce Haffty MD

    Read Inclusion & Exclusion Criteria

    Pre-Registration Eligibility Criteria:

    • Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition
    • No inflammatory breast cancer
    • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
    • All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy * Note: Biopsy of intramammary nodes does not fulfill eligibility criteria
    • Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy * Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled
    • Patients must have completed all planned neoadjuvant chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. anthracycline/cytoxan or taxane chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes * Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist
    • Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial
    • All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy * Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact eligibility
    • No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy
    • No neoadjuvant radiation therapy
    • No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
    • No prior history of ipsilateral breast cancer (invasive disease or ductal carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
    • No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis
    • No history of prior or concurrent contralateral invasive breast cancer; benign breast disease; LCIS or DCIS of contralateral breast is allowed
    • Patients must not be pregnant or nursing * Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potential
    • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

      Intra-Operative Registration/Randomization Criteria:

      • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy
      • A minimum of 1 sentinel node and a maximum of 8 total nodes (sentinel + non-sentinel) are identified and excised; more than 8 nodes identified by either surgeon or pathologist is NOT allowed Note: Patients who do not have an identifiable sentinel lymph node will not proceed to registration/randomization
      • At least one lymph node (sentinel or non-sentinel) excised during sentinel lymph node surgery with a metastasis greater than 0.2 mm in greatest dimension identified on intra-operative pathologic assessment
      • Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)
      • Note: If on final pathology, more than 8 lymph nodes are seen pathologically, then the patient should discontinue study
      • Axillary lymph node dissection (ALND) is not to be performed prior to registration/randomization
      • Note: Patients for whom no positive lymph nodes (sentinel or non-sentinel) are found during sentinel lymph node surgery will not proceed to registration/randomization and can be considered for discussion of the NRG NSABP B-51/RTOG 1304 study "A Randomized Phase III Clinical Trial Evaluating the Role of Post-mastectomy Chest Wall and Regional Nodal XRT and Post-lumpectomy Regional Nodal XRT in Patients with Documented Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy"

        Post-Operative Registration/Randomization Criteria:

        • For cases where ALND has not been performed and one of the following is true: 1) intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive lymph node (sentinel or non-sentinel) with metastasis greater than 0.2 mm OR 2) lymph node (sentinel or non-sentinel) considered negative on intra-operative evaluation was found to be positive on final pathology (with metastasis greater than 0.2 mm)
        • Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of the last dose of neoadjuvant chemotherapy; negative margin (by either breast conservation or mastectomy) on final pathology where negative margin is defined as no tumor on ink
        • At least one lymph node (sentinel or non-sentinel) with a metastasis greater than 0.2 mm in greatest dimension identified on final pathology (for cases where intra-operative evaluation was not performed, or was negative and completion dissection was not performed)
        • At least one and no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised during sentinel lymph node procedure Note: Isolated tumor cells (metastases less than or equal to 0.2 mm) will be treated as node negative disease (N0i+)
        • For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomization

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
  • A011801: The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 Compared with T-DM1 and Tucatinib. - NCT04457596

    Primary Objective: To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy. Secondary Objectives: 1. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) improves the following: - overall survival (OS) - breast cancer free survival (BCFS) - distant recurrence-free survival (DRFS) - disease-free survival (DFS) - brain metastases-free survival (BMFS). 2. To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with T-DM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases. View All Details

    • Protocol Number:
      042106

    • Principal Investigator:
      Coral Omene MD, PhD

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Tucatinib/Placebo ado-trastuzumab/T-DM1

      • Contacts:

      • Rutgers University Prinicipal Investigator: Coral Omene MD, PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • HER2-positive status will be based on pretreatment biopsy material and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) according to current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Central testing is not required * Known hormone receptor (HR) status as defined by ASCO/CAP guidelines (based on pretreatment biopsy material). Hormone receptor positive status can be determined by either known positive estrogen receptor (ER) or known positive progesterone receptor (PR) status; hormone receptor negative status must be determined by both known negative ER and known negative PR
    • Patients with clinical stage T1-4, N0-3 disease at presentation and residual invasive disease postoperatively as defined above are eligible. (Note: Patients with T1a/bN0 tumors are not eligible at initial breast cancer diagnosis are not eligible)
    • Patients with residual HR-negative, HER2 positive (+) disease in the breast and/or lymph nodes per the surgical pathology report are eligible; however, patients with HR+ HER2+ cancers must have node-positive residual disease per the surgical pathology report in order to qualify for the study. The presence of residual invasive disease in the breast is not mandatory for these patients
    • Patients with weakly ER-positive (1-10%) breast cancer (based on the pretreatment core biopsy) are eligible even if they have node-negative disease per the surgical pathology report
    • The residual disease tissue (breast and/or lymph nodes) is not required to be HER2-positive, as eligibility for NCI-2020-03770 (A011801) is based on a positive HER2 status at the time of the initial breast cancer diagnosis * Note: The presence of micrometastases in lymph nodes after preoperative therapy counts as residual disease, whereas the presence of isolated tumor cells does not
    • Patients with synchronous bilateral invasive disease are eligible provided both lesions were confirmed to be HER2-positive, and at least one of the lesions meets the criteria outlined above. Multifocal disease is allowed, as long as the largest biopsied breast tumor was HER2-positive
    • Patients must have received neoadjuvant chemotherapy with one of the following regimens: docetaxel/trastuzumab/pertuzumab (THP), paclitaxel/methotrexate/cisplatin (TMP), doxorubicin/cyclophosphamide/paclitaxel/trastuzumab/pertuzumab (AC-TH(P)); docetaxel/carboplatin/trastuzumab/pertuzumab (TCH(P)); fluorouracil/doxorubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FAC-TH(P)), or fluorouracil/epirubicin/cyclophosphamide-docetaxel/trastuzumab/pertuzumab (FEC-TH(P)). Note: apart from TCHP, where T is docetaxel, treatment with docetaxel or paclitaxel is acceptable
    • Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
    • Prior treatment must have consisted of >= 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of >= 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or Food and Drug Administration [FDA]-approved biosimilars). Patients who have received at least 9 weeks of preoperative taxane, pertuzumab and margetuximab are also eligible if they received >= 6 cycles of systemic therapy prior to enrollment. Note: Patients who complete at least nine of a planned twelve doses of weekly paclitaxel, or three of a planned four doses of docetaxel, but discontinue prematurely due to toxicity are eligible. Patients receiving dose-dense chemotherapy regimens are also eligible. Prior use of nab-paclitaxel (Abraxane) instead of paclitaxel or docetaxel is permitted. Prior use of subcutaneous trastuzumab (Hylecta) and subcutaneous trastuzumab and pertuzumab (Phesgo) is also allowed.
    • Patients who received neoadjuvant systemic therapy which included experimental HER2-targeted therapy/therapies are potentially eligible, as long as the investigational agent was not a HER2-targeted antibody-drug conjugate (e.g. T-DM1, DS-8201a [trastuzumab deruxtecan]) or a HER2 targeted tyrosine kinase inhibitor (TKI) (e.g. tucatinib, lapatinib, neratinib).
    • Patients may have received =< 1 cycles of T-DM1 in the adjuvant setting. Note: These patients will be randomized to receive a further 14 cycles of T-DM1 and tucatinib/placebo as tolerated. The most recent cycle of T-DM1 should have been administered =< 5 weeks prior to registration * Note: Both of the following two criteria need to be met for the patient to be eligible for this study
    • An interval of no more than 12 weeks between the completion date of the last definitive treatment (e.g. postoperative chemotherapy or radiation, or if neither given, breast surgical date) and the date of registration. Concurrent radiation therapy is permitted while receiving study treatment
    • Patients must be registered on study within =< 180 days of the date of the most recent definitive breast cancer surgery (not including reconstructive surgery)
    • All systemic chemotherapy should have been completed preoperatively unless participating in EA1181 (CompassHER2 pathologic complete response [pCR]) or the BIG DECRESCENDO Trial (which is very similar to CompassHER2 pCR in terms of study design, drugs, and eligibility). However, patients who received 4 cycles of neoadjuvant THP off study can receive a further 2-4 cycles of chemotherapy postoperatively to meet eligibility for A011801. Patients who participated in EA1181 or MA41 and proceeded to surgery immediately after the de-escalated trial regimen must receive postoperative chemotherapy to complete a total of >= 6 cycles of systemic treatment prior to enrollment on A011801, as outlined above (e.g. 4 cycles pre-operatively, and 2 cycles post-operatively). The postoperative chemotherapy regimen prescribed is at the discretion of the treating oncologist (i.e. 2-4 cycles AC or THP, other). Continuation of trastuzumab + pertuzumab (HP) pre- or post-operatively as maintenance therapy (while awaiting a surgical date or an official pathology report) is allowed for all study participants
    • Toxicities related to prior systemic treatment should have resolved or be at baseline, apart from alopecia and peripheral neuropathy =< grade 1
    • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as follows:
    • Breast surgery: total mastectomy with no gross residual disease at the margin of resection, or breast-conserving surgery with histologically negative margins of excision
    • For patients who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. Patients with margins positive for classic lobular carcinoma in situ (LCIS) are eligible without additional resection
    • Lymph node surgery ** The axilla needs to be evaluated with either sentinel node biopsy or axillary lymph node dissection. If patients have a sentinel lymph node biopsy and sentinel nodes are negative, no further axillary treatment is necessary. If patients have isolated tumor cells (ITCs) in the setting of residual breast disease, at least one of the following is required: axillary lymph node dissection (ALND) or planned nodal irradiation. If patients have micro- or macro-metastatic nodal disease, ALND and planned nodal irradiation are required. Of note, co-enrollment on Alliance A011202 is not allowed
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
    • Absolute neutrophil count (ANC) >= 1,000/mm^3
    • Hemoglobin >= 8 g/dL (Note: packed red blood cells [PRBC] transfusion is not permitted to achieve eligibility)
    • Platelet count >= 100,000/mm^3
    • Creatinine =< 1.5 x upper limit of normal (ULN)
    • Total bilirubin =< 1.0 x upper limit of normal (ULN) or direct bilirubin within the institutional normal range for patients with Gilbert's syndrome
    • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
    • Screening left ventricular ejection fraction (LVEF) >= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute percentage points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >= 55% after completion of neoadjuvant chemotherapy. Note: LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility

    Exclusion Criteria:

    • No adjuvant treatment with any anti-cancer investigational drug within 28 days prior to registration
    • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum pregnancy test done =< 7 days prior to registration is required
    • Patients with known active and/or untreated hepatitis B or hepatitis C or chronic liver disease are ineligible. Patients with a diagnosis of hepatitis B or C that has been treated and cleared and normal liver function are eligible to participate in the study if the other eligibility parameters are met
    • Stage IV (metastatic) breast cancer
    • History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
    • Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
    • Evidence of recurrent disease following preoperative therapy and surgery
    • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
    • History of exposure to the following cumulative doses of anthracyclines: doxorubicin > 240 mg/m^2; epirubicin or liposomal doxorubicin-hydrochloride (Myocet) > 480 mg/m^2. For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m^2
    • Cardiopulmonary dysfunction as defined by any of the following:
    • History of National Cancer Institute (NCI) CTCAE version (v) 5.0 grade >= 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria class >= II
    • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
    • High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade atrioventricular block (AV)-block (second degree AV-block type 2 [Mobitz 2] or third degree AV-block)
    • Significant symptoms (grade >= 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy
    • History of a decrease in left ventricular ejection fraction (LVEF) to < 40% with prior trastuzumab treatment (e.g., during preoperative therapy)
    • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
    • Current severe, uncontrolled systemic disease
    • Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to registration or anticipation of the need for major surgery during the course of study treatment
    • History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
    • Peripheral neuropathy of any etiology that exceeds grade 1
    • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
    • Use of a strong CYP3A4 or CYP2C8 inhibitor within 2 weeks, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to registration is prohibited.
    • Please note that use of sensitive CYP3A substrates should be avoided two weeks before registration and during study treatment. Additionally, CYP3A4 or CYP2C8 inducers are prohibited as concomitant medications within 5 days following discontinuation of tucatinib treatment. Patients who require medications that are known to be sensitive substrates of CYP3A4 with a narrow therapeutic window should be excluded.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Saint Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute of New Jersey
  • A221702 ARM: Axillary Reverse Mapping, - A Prospective Trial To Study Rates Of Lymphedema And Regional Reccurence After Sentinel Lymph Node Biopsy And Sentinel Lymph Node Biopsy Followed By Axillary Lymph Node Dissection With And Without Axillary Reverse Mapping - NCT03927027

    To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no ARM) versus Group II (ARM). View All Details

    • Protocol Number:
      041918

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Breast

      • Contacts:

      • RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset Prinicipal Investigator: Deborah Lue MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      - Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally

        meet one of the following conditions:
      • Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
      • Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
      • Patients will be staged according to the TNM staging system.
      • Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB. o Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.
      • No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration).
      • No bilateral invasive breast cancer.
      • No matted nodes.
      • No history of lymphedema of either arm.
      • No known allergies blue dyes, including make-up containing blue dye.
      • In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
      • Female : Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
      • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
      • Creatinine: =< 1.5 x upper limit of normal (ULN).

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • RWJ University Hospital Somerset
  • An Open-Label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects with Previously Treated Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) - NCT04225117

    Primary Objective: To determine the antitumor activity of enfortumab vedotin as measured by confirmed ORR per investigator assessment. Secondary Objective: To assess other measures of antitumor activity of enfortumab vedotin per investigator assessment; To assess the OS; To assess the safety and tolerability of enfortumab vedotin View All Details

    • Protocol Number:
      052011

    • Principal Investigator:
      Jyoti Malhotra MD, MPH

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Esophagus,Breast,Lung

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Enfortumab vedotin (ASG-22CE)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Jyoti Malhotra MD, MPH

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Subject is considered an adult according to local regulation at the time of signing the informed consent form (ICF).
    • Subject has measurable disease by RECIST Version 1.1.
    • Subject has accessible archival tumor tissue from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study treatment. If no archival tumor tissue is available, the subject will have a biopsy to obtain tumor tissue prior to study treatment. If the subject is unable to undergo a biopsy due to safety concerns, enrollment into the study must be discussed with the medical monitor.
    • Subject has ECOG performance status of 0 or 1.
    • Subject has the following baseline laboratory data. If a subject has received a recent blood transfusion, the hematology tests must be obtained ≥ 28 days after any blood transfusion.
    • absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
    • platelet count ≥ 100 × 10^9/L
    • hemoglobin ≥ 9 g/dL
    • serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for subjects with Gilbert's disease
    • creatinine clearance (CrCl) ≥ 30 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (glomerular filtration rate [GFR] can also be used instead of CrCl).
    • alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN
    • Subject agrees not to participate in another interventional study while receiving study treatment in the present study.
    • Additional contraceptive requirements exist for male and female subjects.

      Disease Specific Inclusion Criteria:

      • Evidence of progression on or after the last regimen received.
      • Locally advanced or metastatic disease that is not amenable to curative intent treatment. Cohort 1: HR+/HER2- breast cancer
      • Subject has histologically- or cytologically-confirmed HR+/HER2- (estrogen receptor [ER] positive and/or progesterone receptor [PR] positive, and HER2 negative) breast cancers and are not considered a candidate for further hormonal therapy. Subject will be considered HR+ if biopsies show ≥ 1% expression of ER or PR as per current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines.
      • Subject has progressed, relapsed, or discontinued for toxicity during or after at least 1 prior cytotoxic regimen, either a taxane or anthracycline in the incurable, unresectable locally advanced or metastatic setting, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting. No limit applies to endocrine therapies.
      • Prior cytotoxic regimen received in the neoadjuvant or adjuvant setting will count as a prior cytotoxic regimen if disease recurrence occurred during or within 6 months of completing the regimen.
      • Subject has progressed, relapsed, or discontinued for toxicity during or after receiving endocrine or hormonally directed therapy with cyclin-dependent kinase (CDK) inhibitors. Cohort 2: triple negative breast cancer (TNBC)
      • Subject has histologically- or cytologically-confirmed TNBC; defined as unequivocal TNBC histology (ER-negative/PR-negative/HER2-negative). This is defined by < 1% expression of ER and PR by immunohistochemistry (IHC), and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization (FISH) negative (not amplified) as per current ASCO/CAP guidelines.
      • Subject has progressed, relapsed, or discontinued for toxicity during or after at least 1 prior cytotoxic regimen, either a taxane or anthracycline in the incurable, unresectable locally advanced or metatstatic setting, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
      • Prior cytotoxic regimen received in the neoadjuvant or adjuvant setting will count as a prior cytotoxic regimen if disease recurrence occurred during or within 6 months of completing the regimen.
      • Subject has received prior therapy with an anti-programmed cell death protein-1 (PD-1) or an anti-programmed cell death-ligand 1 (PD-L1) based on subject's tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed or discontinued treatment due to toxicity, or therapy is contraindicated for subject. Cohort 3: squamous non-small cell lung cancer (NSCLC)
      • Subject has histologically or cytologically-confirmed squamous NSCLC.
      • Subjects with mixed histology NSCLC are eligible provided there is not any component of neuroendocrine histology.
      • Subjects with known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), reactive oxygen species (ROS), BRAF, or other actionable mutations are eligible if treated with mutation targeted therapy and have progressed, relapsed, or discontinued treatment due to toxicity.
      • Subject has either:
      • progressed, relapsed, or discontinued treatment due to toxicity after 1 platinum based therapy for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting. (a.) Maintenance therapy does not constitute a new chemotherapy regimen provided there was no progression after the initial platinum-based regimen.(b.) Changing chemotherapy agents during platinum-based treatment for the management of toxicities does not constitute a new chemotherapy regimen provided no progression had occurred while on the initial therapy, or
      • progressed or relapsed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiation regimen for early stage or locally advanced stage disease.
      • Subject has received prior therapy with an anti-programmed cell death protein-1 (PD-1) or anti-programmed cell death-ligand 1 (PD-L1) based on subject's tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject. Cohort 4: non-squamous non-small cell lung cancer
      • Subject has histologically- or cytologically-confirmed non-squamous NSCLC.
      • Subjects with mixed histology NSCLC are eligible provided there is not any component of neuroendocrine histology.
      • Subjects with known EGFR, ALK, ROS, BRAF, or other actionable mutations are eligible if treated with mutation targeted therapy and have progressed, relapsed, or discontinued treatment due to toxicity.
      • Subject has either:
      • progressed, relapsed, or discontinued treatment due to toxicity after 1 platinumbased therapy for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.(a.) Maintenance therapy does not constitute a new chemotherapy regimen provided there was no progression after the initial platinum-based regimen. (b.) Changing chemotherapy agents during platinum-based treatment for the management of toxicities does not constitute a new chemotherapy regimen provided no progression has occurred while on the initial therapy, or
      • progressed or relapsed within 6 months of last dose of platinum-based adjuvant, neoadjuvant, or concomitant chemoradiation regimen for early stage or locally advanced stage disease.
      • Subject has received prior therapy with an anti-PD-1 or anti-PD-L1 based on subject's tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject. Cohort 5: head and neck cancer
      • Subject has histologically- or cytologically-confirmed head and neck cancer.
      • Primary tumor site must arise from the oral cavity, oropharynx, hypopharynx, and larynx; tumors arising from the nasopharynx are excluded.
      • Subject has progressed, relapsed, or discontinued treatment due to toxicity after 1 platinum-based therapy for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
      • Platinum regimens administered as part of multimodal therapy in the curative setting will count as a regimen if relapse occurred ≤ 6 months after completion.
      • Subject has received prior therapy with an anti-PD-1 or anti-PD-L1 based on subject's tumor PD-1 or PD-L1 expression and local treatment guidelines and has progressed, relapsed, or discontinued treatment due to toxicity, or therapy is contraindicated for subject. Cohort 6: gastric or gastroesophageal junction (GEJ) or esophageal cancer
      • Subject has histologically- or cytologically-confirmed gastric, GEJ, or esophageal cancer.
      • Subject has progressed, relapsed, or discontinued due to toxicity after 1 platinum-based therapy for locally advanced or metastatic disease, and has not received > 2 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
      • Neoadjuvant or adjuvant regimens will count as a prior regimen if relapsed or progressed ≤ 6 months after completion.
      • Subject must have received a HER2 directed therapy if known to have HER2 positive cancer.

      Exclusion Criteria:

      • Subject has preexisting sensory or motor neuropathy Grade ≥ 2.
      • Subject has active central nervous system (CNS) metastases. Subjects with treated CNS metastases are permitted on study if all the following are true:
      • CNS metastases have been clinically stable for ≥ 6 weeks prior to screening
      • If requiring steroid treatment for CNS metastases, the subject is on a stable dose ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks
      • Baseline imaging scans show no evidence of new or enlarged brain metastasis
      • Subject does not have leptomeningeal disease
      • Subject has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
      • Subjects with ongoing ≥ Grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded. Subjects with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or subjects with other immunotherapy-related AEs requiring high doses of steroids (> 20 mg/day of prednisone or equivalent), are excluded. Subject with ≤ Grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well maintained/controlled on a stable dose of hormone replacement therapy (if indicated).
      • Subject has a history of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8% or HbA1c between 7 and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
      • Subject has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs).
      • Subject has a second malignancy diagnosed within 3 years before first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Subjects with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.
      • Subject is currently receiving systemic antimicrobial treatment for viral, bacterial, or fungal infection at the time of first dose of study treatment. Routine antimicrobial prophylaxis is permitted.
      • Subject has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or active hepatitis C (e.g., hepatitis C virus [HCV] RNA [qualitative] is detected).
      • Subject has known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2).
      • Subject has documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug.
      • Subject has major surgery within 4 weeks prior to first dose of study drug.
      • Subject had radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug.
      • Subject has known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) OR subject has known hypersensitivity to biopharmaceutical produced in Chinese hamster ovary cells.
      • Subject has known active keratitis or corneal ulcerations. Subject with superficial punctate keratitis is allowed if the disorder is being adequately treated.
      • Subject has any condition which makes the subject unsuitable for study participation.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Awareness, attitudes, and apprehensions about breast cancer among South Asians living in the U.S

    1. To assess awareness, attitudes and apprehensions about breast cancer among South Asian women who were never previously diagnosed with any cancer; 2. To assess awareness, attitudes and apprehensions about survivorship, cancer care and follow-up care among female South Asian breast cancer survivors; and 3. To assess healthcare professionals experiences about South Asians awareness, attitudes and apprehensions about breast cancer, preventive care, cancer care, and follow-up care. View All Details

    • Protocol Number:
      132013

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Breast

      • Contacts:

      • School of Public Health Prinicipal Investigator: Jaya Satagopan
    • Rutgers Cancer Institute of New Jersey
  • BTCRC-BRE16-042: A Phase II Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients: Big Ten Cancer Research Consortium - NCT03393845

    Primary Objective: To evaluate the overall response rate (ORR) of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. Secondary Objectives: 1) To describe the toxicity profile of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. 2) To estimate the progression free survival of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. 3) To estimate the durable response rate of pembrolizumab plus fulvestrant in patients with hormone receptor positive, HER2 negative advanced/metastatic breast cancer. Exploratory Objectives: 1) To evaluate whether the tumor genomic profile will be associated with response to pembrolizumab, includes total mutation burden, mutation pattern and identification of mutations in specific immunoregulatory genes that may be potential predictors of response to these therapies. 2) To measure PD-L1 expression in tumor biopsies in pre-treatment to capture data on the relationship between PD-L1 expression and patient outcome 3) To perform tumor gene expression profiling for PDL1, LAG3, and other immune related genes for associations with clinical outcomes that may be potential predictors of response to these therapies. View All Details

    • Protocol Number:
      041705

    • Principal Investigator:
      Coral Omene MD, PhD

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Breast - Female,Breast - Male

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      FULVESTRANT Pembrolizumab (MK-3475)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Coral Omene MD, PhD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    • Men [29] and women ≥ 18 years of age at the time of informed consent.
    • ECOG Performance Status of 0 or 1 within 28 days prior to registration.
    • Histologic or cytologic diagnosis of metastatic breast cancer
    • Has received no more than two lines of prior hormonal therapy for advanced non-resectable/metastatic disease or no more than two lines of prior chemotherapy for advanced non-resectable/metastatic disease. Prior or current fulvestrant is allowed. Combination therapy is considered as one regimen.
    • Tumor is estrogen receptor positive (ER+) and/or (PR+), HER-2 negative (HER2-). ER and PR positivity is defined as >1%. HER-2 negative is defined as by IHC (0, 1+) or FISH. HER2 positive test result includes: Single-probe average HER2 copy number ≥6.0 signals/cell; Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2; copy number ≥4.0 signals/cell; Dual-probe HER2/CEP17 ratio ≥2.0 with an average HER2copy number <4.0 signals/cell; or Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number ≥6.0 signals/cell. Equivocal findings for IHC as 2+ should be reflexed to FISH. Equivocal results by FISH may be considered with approval from the Sponsor-Investigator.
    • Measurable disease based on RECIST 1.1 within 28 days prior to registration. Except in patients with bone-only disease, in the absence of measurable disease, evaluable bone lesion is allowed. NOTE: Bone-only disease is allowed and biopsy is required. -Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. NOTE: Subjects for whom newly-obtained fresh tissue samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor-Investigator.
    • Normal cardiac function as determined by treating physician per institutional standards via echocardiogram (ECHO) performed within 28 days prior to registration.
    • Prior chemotherapy must be completed at least 28 days prior to registration or at least 14 days prior to registration for targeted therapy.
    • Prior hormonal therapy or radiation therapy must be completed at least 14 days prior to registration. If subject is currently receiving fulvestrant, it may continue without interruption as per standard of care.
    • The subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline. NOTE: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. NOTE: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to study registration, as determined by the enrolling physician.
    • Demonstrate adequate organ function as defined in the table below; all screening labs will be performed within 28 days of study registration.
    • Hematological ---Absolute Neutrophil Count (ANC): ≥ 1500/mm3 ---Platelets: ≥100,000 / mcL
    • --Hemoglobin (Hgb): ≥ 9 g/dL or ≥5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
    • Renal
    • --Serum creatinine OR Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × upper limit of normal (ULN) OR ≥30 mL/min for subjects with creatinine levels > 1.5 × institutional ULN
    • Hepatic
    • --Serum total bilirubin: ≤ 1.5 X ULN OR
    • --Direct bilirubin ≤ ULN for subjects with total bilirubin levels: > 1.5 ULN
    • --AST (SGOT) and ALT (SGPT): ≤ 2.5 × ULN
    • --Albumin: >2.5 mg/dL
    • Coagulation
    • International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT): ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • aCreatinine clearance will be calculated per institutional standard.
    • Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to study registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. NOTE: Females are considered of childbearing potential unless: they are postmenopausal; are surgically sterile; or they have a congenital or acquired condition that prevents childbearing. See Section 5.6.2 for definitions. NOTE: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
    • Females and males of reproductive potential must be willing to abstain from heterosexual activity which could result in pregnancy or agree to use an adequate method of contraception as outlined in Section 5.6.2. Hormonal contraceptives are contraindicated in this population and are not allowed. Contraception will begin from the time of informed consent through 120 days after the last dose of study drug(s).

    Exclusion Criteria:

    • Is currently receiving an investigational agent or has received an investigational agent or used an investigational device within 28 days of study registration.
    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Has a known history of active TB (Bacillus Tuberculosis). NOTE: TB testing is not required.
    • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). NOTE: HIV testing is not required.
    • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). NOTE: Hepatitis B and Hepatitis C testing is not required.
    • Hypersensitivity to pembrolizumab or any of its excipients.
    • Has received prior chemotherapy within 28 days prior to study registration or has received prior hormonal/targeted therapy within 14 days prior to study registration
    • More than two lines of chemotherapy or more than two lines of hormonal therapy excludes participation.
    • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
    • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
    • Has known history of non-infectious pneumonitis/interstitial lung disease that required steroids or has any evidence of active pneumonitis/interstitial lung disease.
    • Has known history of, or any evidence of active interstitial lung disease, Class II-IV congestive heart failure, or myocardial infarction within 6 months from randomization.
    • Active infection requiring systemic therapy.
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
    • Breastfeeding during the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment. NOTE: breast milk cannot be stored for future use while the mother is being treated on study.
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
    • Has received a live vaccine or live-attenuated vaccine within 30 days of study registration. Administration of killed vaccines is allowed.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
Page of 3