Clinical Trial Provides Lifesaving Care for Women Who Have Triple-Negative Breast Cancer

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The director of the Breast Cancer Center at NYU Langone’s Perlmutter Cancer Center, Dr. Sylvia Adams, 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 outcomes for patients who experienced a recurrence of or who had 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, the 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. 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, Candace Nicoleau, Choi Ling Blakey, and Samantha Bader, enrolled in the study because of Dr. Adams. Five years later, Bader is still being treated with chemotherapy and immunotherapy, while Nicoleau and Blakey remain cancer-free.

Trusting an Experimental Treatment

When Candace Nicoleau, a Black woman in her 30s, first found out that her cancer had returned, she was skeptical of an experimental treatment.

Because of the open communication and trust established between Dr. Sylvia Adams and Candace Nicoleau, Nicoleau joined a clinical trial, and now the cancer is in remission.

Photo: NYU Langone Staff

“Candace didn’t really trust the medical community, and I did not dismiss her concerns,” says Dr. Adams, who is also a professor in the Department of Medicine at NYU Grossman School of Medicine.

Dr. Adams’s understanding of her hesitancy, as well as interactions with a Black nurse practitioner on her team, established trust. “Nurse practitioner Akilah Bryant said, ‘You’re in good hands,’ and I trusted that,” says Nicoleau. “And so I decided to join the clinical trial.”

From the moment treatment began, Nicoleau says her care team was engaged and available to answer every question, assess and prevent possible side effects, and provide support. For Nicoleau, 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, Nicoleau began a regular weight-lifting regimen that she maintains today.

Hope for Metastatic Cancer

When Choi Ling Blakey, the sole provider for her three sons and mother, was diagnosed with TNBC at age 54, 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 Blakey’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,” says Blakey. “The trial gave me an option, and one that could help save my life.”

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

A Combination Therapy That Worked

Samantha Bader was a 21-year-old college student when she found out that she had a rare subtype of TNBC: metaplastic breast cancer, which has an even worse prognosis than most other forms of 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 Bader with Dr. Adams. Bader was a perfect candidate for the trial.

On meeting Dr. Adams, Bader was overwhelmed with emotion. “When I met Dr. Adams, I cried,” says Bader. “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.”

Bader 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 Blakey, Bader received a custom hybrid treatment consisting of immunotherapy, additional chemotherapy, and radiation. Although Bader is still having chemotherapy and immunotherapy treatments, she is able to focus on enjoying life with her boyfriend, family, and new dog, George.

Long-Lasting, Successful Breast Cancer Treatment

The courage of these three women to try an experimental treatment had widespread implications: the U.S. Food and Drug Administration has since 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 the patients who need it.

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

“I survived with Dr. Adams’s help,” Blakey says. “She gave me more birthdays.”

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