Clinical Trial Provides Lifesaving Treatment for Breast Cancer Patients

Dr. Sylvia Adams, director of the Breast Cancer Center at NYU Langone’s Perlmutter Cancer Center, has spent her career focused on this hypothesis: The key to long-lasting cancer treatment is to activate the body’s own immune system, enlisting it in the fight against the disease. 

Her research indicated that a treatment with an immunotherapy drug such as pembrolizumab could improve the outcomes for patients who experienced a recurrence of or had metastatic triple negative breast cancer (TNBC), one of the most aggressive and hardest-to-treat kinds of breast cancer. 

There was only one way to find out if her theory was correct: a clinical trial. So, in early 2015 she proposed a study concept to Merck (maker of pembrolizumab). With the company’s approval and support, in 2017 she enrolled 50 participants to answer the question of whether pembrolizumab, in conjunction with chemotherapy, would halt progression in people with TNBC. The trial was later amended to include an additional 20 patients. By the time the trial had concluded, more than half of the patients had experienced a benefit, either in tumor shrinkage or stabilization.

Three of those patients, Carol*, Kai Lei*, and Sarah*, enrolled in the study because of Dr. Adams. Five years later, all remain cancer-free.

Trusting an Experimental Treatment

When Carol, a young Black woman, first found out that her cancer returned, she was skeptical of an experimental treatment.

“Carol didn’t really trust the medical community, and I did not dismiss her concerns,” - Dr. Adams. 

However, interactions with Dr. Adams and a Black nurse on her team established a solid foundation of trust. “That nurse practitioner said, ‘You’re in good hands,’ and I trusted that,” says Carol. “And so, I decided to join the clinical trial.”

From the moment treatment began, Carol says her care team was engaged and available to answer every question, assess and prevent possible side effects, and provide support. For Carol, Pembrolizumab had so few side effects and was so effective that the additional chemotherapy could soon be stopped. As she went into remission and built her strength, Carol began a regular weightlifting regimen that she maintains today.

Hope for Metastatic Cancer

When Kai Lei, the sole provider for her three sons and mother, was diagnosed with TNBC in early middle age, she was in shock.

Dr. Adams guided her through treatments after her initial diagnosis, and again when scans and blood work revealed that the cancer had metastasized to Kai Lei’s liver. Dr. Adams again had a solution, this time in the form of her recently opened clinical trial.

“When Dr. Adams told me about the trial, I couldn’t sign the enrollment form fast enough. The trial gave me an option, and one that could help save my life.” - Kai Lei

Dr. Adams customized Kai Lei’s treatment to also include an ablation procedure to help provide additional treatment for liver tumor, resulting in remission that has lasted to this day.

A Combination Therapy that Worked

Sarah was a college junior when she found out that she had a rare subtype of TNBC: metaplastic breast cancer (which has an even worse prognosis than TNBC). She had a double mastectomy and was about to begin radiation when she learned the cancer had already returned. Her surgeon who had heard a recent talk by Dr. Adams discussing an unprecedented response of metaplastic breast cancer to immunotherapy connected Sarah with Dr. Adams.

Sarah was a perfect candidate for the trial. Upon meeting Dr. Adams, Sarah was overwhelmed with emotion.

“When I met Dr. Adams, I cried. She was so calm and positive, though. She reassured me that no matter what came up, we would figure it out together. She made me feel comfortable, calm, and safe.” - Sarah

Sarah enrolled in the trial, and the initial results were positive: pembrolizumab halted the cancer’s growth. But Dr. Adams wanted to ensure the tumor itself shrank as well. Much like Kai Lei, Sarah received a custom, hybrid treatment consisting of immunotherapy, additional chemotherapy and radiation. And it worked. With cancer in remission, Sarah is now able to focus on enjoying life with her boyfriend, family, and new cat, Gary*.

Long-lasting, Successful Breast Cancer Treatment

More than five years later, all three women are still in remission. But their courage to try an experimental treatment had far further implications: to date, the Food and Drug Administration (FDA) has approved the medication, now known by the trade name Keytruda, for metastatic TNBC in combination with standard chemotherapy and for early stage TNBC. This made the treatment widely available to patients who need it.

For Dr. Adams patients' early access to an experimental treatment provided hope and additional years they weren’t sure they would have. When Kai Lei reached her 60th birthday this year, Dr. Adams made the guest list.

“I survived with Dr. Adams’ help. She gave me more birthdays.” - Kai Lei

*Names and identifying information have been changed or removed for privacy.