Kalyani G Clinical Trial May Prevent Woman's Breast Cancer From Returning

"Knowing that I was doing something more helped me mentally...I liked that I was doing something to keep fighting.”

Kalyani Gadgil of Edison was just past her 40th birthday in 2019 when she was diagnosed with breast cancer after noticing some skin discoloration and changes in the shape of her left breast. A mammogram and other tests found she had stage 2 cancer that already had spread to a lymph node in her underarm. A later biopsy revealed her cancer had reached stage 3.

Being so young, with a husband and two children at home, Kalyani had a lot to live for, and was determined to fight. Working in partnership with her multidisciplinary health care team at Robert Wood Johnson University Hospital (RWJUH) Somerset, Kalyani conquered her cancer with a double mastectomy, radiation therapy and six months of oral chemotherapy. However, she then went a step further.

Kalyani decided in June 2020 to participate in a clinical trial that promised to boost her body’s immune system and help prevent the cancer from coming back. “I wanted to do everything I could to fight the cancer and any recurrence,” says Kalyani, now 42. “My physician told me that the immunotherapy used in the clinical trial has fewer side effects than chemotherapy or radiation, so I figured if it’s not likely to harm anything and may help prevent the cancer from growing again, I should try it.”

A Wealth of Trials

It was Kalyani’s medical oncologist who suggested she consider enrolling in the clinical trial, which was available through RWJUH Somerset’s partnership with Rutgers Cancer Institute of New Jersey, the state’s only NCI-Designated Comprehensive Cancer Center. Rutgers Cancer Institute currently offers more than 200 clinical trials on a wide range of cancers. RWJUH Somerset is participating in about two dozen of these trials for cancers of the breast, colon, lung, prostate and other organs, says Maria Scibilia, RN, Director of Oncology Research at RWJUH Somerset’s Steeplechase Cancer Center.

Patients can benefit from participating in clinical trials that test new treatments by gaining access to top-notch medical care and cutting-edge therapies. “Often cancer patients participating in clinical trials have exhausted standard care options,” Scibilia says. “A trial offers them different opportunities.”

In Kalyani’s trial, researchers are investigating whether taking the drug pembrolizumab (Keytruda®) helps boost immunity and prevent cancer recurrence better than having no additional therapy. Kalyani joins more than 1,100 patients participating in the trial across the United States and Canada. All have been treated successfully for triple-negative breast cancer—a type of cancer that is estrogen-receptor, progesterone-receptor and HER2 negative. Triple-negative breast cancer patients do not respond to treatments such as hormone blockers and HER2 blockers that are used in many other breast cancer patients, explains Heather Davis, RN, a research nurse at Steeplechase Cancer Center who has worked with Kalyani.

Researchers hope that pembrolizumab—already used in other ways to treat patients with a variety of cancers, including certain groups of breast cancer patients—will be an effective tool for patients like Kalyani who can’t benefit from using other breast cancer medications to help stave off a recurrence, Davis says. The trial will follow participants up to 10 years to find out.

Continuing the Battle

During the trial, Kalyani received half-hour intravenous infusions of pembrolizumab every three weeks for about a year at RWJUH Somerset, finishing in June 2021. She experienced some drowsiness and joint pain from the treatment but no discomfort that exercise such as yoga and walking couldn’t ease.

Kalyani checks in with her doctor every few months and is thankful she had an opportunity to try an approach that may guard her future. “It was great to participate in the trial,” says Kalyani. “Knowing that I was doing something more helped me mentally as well. I liked that I was doing something to keep fighting.”

Two years battling cancer and worrying about the impact on her family had been a nightmare. Now Kalyani says she is feeling great, has her energy back and can fully take care of her kids and home. “I can enjoy my family again,” she says.

How to Join a Clinical Trial

If you’re interested in enrolling in a cancer clinical trial, ask your physician if you might be eligible for an available study, advises Maria Scibilia, RN, Director of Oncology Research at Robert Wood Johnson University Hospital (RWJUH) Somerset’s Steeplechase Cancer Center. “Our physicians are very aware of all clinical trials we have to offer and which ones might potentially be best for a patient,” she says.

If your doctor feels you might be a good candidate for a trial, you’ll be referred to Scibilia’s team, which will further evaluate whether the study is a good fit for you—and vice versa. If you’re cleared to participate, the team will advise you on how to get started.

How Clinical Trials Benefit Patients

Participating in clinical trials can offer patients a number of advantages, says Maria Scibilia, RN, Director of Oncology Research at Robert Wood Johnson University Hospital (RWJUH) Somerset’s Steeplechase Cancer Center. These include:

  • Contact with top specialists who conduct research, are highly knowledgeable about the latest treatments and can help patients receive optimal care.
  • Access to cutting-edge treatments and protocols not yet available to the general population that may help patients live longer or improve their quality of life. Such therapies may only be available at an NCI-Designated Comprehensive Cancer Center such as Rutgers Cancer Institute of New Jersey, where the necessary expertise, resources and equipment allow clinicians to do groundbreaking research and provide patients access to the most advanced therapies close to home.
  • The satisfaction of not only potentially benefiting directly from an investigative therapy but also being part of a study that could help other patients in the future.

Learn more about cancer care at RWJUH Somerset.