Norwalk Hospital reports positive results with breast cancer clinical trials

In Clinical Trials by Barbara Jacoby

By: Kevin Zimmerman

From: westfaironline.com

Four cutting-edge breast cancer clinical trials recently launched at Norwalk Hospital’s C. Anthony and Jean Whittingham Cancer Center are giving hope to patients diagnosed with triple negative breast cancer, an aggressive form of the disease that cannot be treated with hormone therapies or other cancer-fighting drugs.

“We started about six months ago,” said Dr. Linda Vahdat, chief of medical oncology and clinical director of cancer services at Norwalk Hospital, and breast medical oncologist at New York’s Memorial Sloan Kettering Cancer Center. “And what we’ve seen so far has been encouraging.”

The trials are being conducted in a partnership between Norwalk and MSK. Norwalk is the first hospital in the state to offer all four trials. Vahdat noted that one trial is also being offered at Danbury and New Milford hospitals, which, like Norwalk, are part of the Western Connecticut Health Network.

Triple negative breast cancer (TNBC) gets its name from the fact that the three most common types of receptors known to promote most breast cancer growth — estrogen, progesterone and the HER2/neu gene — are not present in the tumor. That means that a triple negative tumor does not respond to common breast cancer treatments that target those three receptors.

According to the American Cancer Society, some 40,000 people worldwide — 20,000 in the U.S. — are diagnosed with TNBC each year.

“It can be very tough to treat,” Vahdat said. “But it’s very exciting to be involved with these trials and to see what can be done with these drugs.”

The main drug in question is sacituzumab govitecan, also known as IMMU-132, which earlier this year received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the treatment of patients with TNBC who have failed at least two prior therapies for metastatic disease. Several other types of immunotherapies are also part of the four clinical trials.

Vahdat said the response rate to date for Norwalk’s trials is “around 34 percent — it’s usually zero percent for these kinds of patients.” The median overall survival is six to13 months.

“Through these clinical trials, we have an opportunity to connect patients who have advanced and aggressive forms of breast cancer with world-class doctors and treatment options,” Vahdat said. “In addition to giving hope to patients and their families, these clinical trials also minimize the stress of traveling for treatment by providing local patients with access to cutting-edge, community-based care.”

One patient who has benefited from the therapy at Norwalk is Neania Buehler, a 59-year-old U.S. Army veteran who works as an education technician at the United States Military Academy at West Point. Having been first diagnosed with TNBC on Christmas Eve in 2014, Buehler had a lumpectomy to remove a tumor in her left breast followed by infusion chemotherapy and radiation.

She was in remission from October 2016 to August 2017, until she developed a persistent cough that led to a computed tomography (CT) scan, which showed not only that her cancer had returned, but that it had also spread to her lungs. Buehler was diagnosed with metastatic TNBC on Aug. 30, 2017.

“Even though we knew I was at risk of my cancer coming back because of the type I had, my husband and I were at first devastated,” she recalled. “But we also felt stronger this time. We said, ‘OK, we’ve done this before. Let’s figure out what to do next.’ So I started an oral chemotherapy treatment.”

Her advanced breast cancer led to pneumonia. Buehler was hospitalized twice for pneumonia and spent five days in intensive care, during which time she lost 50 pounds. She also learned that the oral chemotherapy was not effectively treating her cancer.

Together with her husband Manfred, Buehler began looking for a solution. That search ultimately took her to Norwalk, where she began treatment in the IMMU-132 clinical trial on April 4.

“I didn’t meet the criteria to participate in other clinical trials we inquired about because I had already received prior treatment for cancer,” she noted. “I was also not a candidate because of my ill health from the pneumonia. So when I learned that I was not only accepted into the clinical trial at Norwalk Hospital, but that I was also getting the treatment drug, I felt so hopeful.”

Buehler added: “Without options like this clinical trial and without a supportive care team, family, friends, and colleagues, it’s so much harder to fight this disease. It’s like putting an army together.

“We feel like we’re in a safe place now and we have the right tools to fight,” she remarked. “We’re going to continue to fight.”

Vahdat, who is Buehler’s medical oncologist, said she was pleased with such results. “The worst side effect is hair loss,” she said. “And by doing the trials here, patients don’t have to go to Boston or New York for treatment.

“This looks like the real deal,” she concluded.

Vahdat further noted that the hospital is continuing to accept applications to join the trial, and that it is open to men as well as women.

Interested parties should call 203-852-2996 or visit MSKatNorwalk.org to learn more about the clinical trials.