In an ongoing study, a new chemotherapy drug has shown success in treating patients with triple-negative breast cancer (TNBC), an unusually aggressive form of the disease. Janisette Rivera-Rollins is the first Central Florida patient to participate in the global clinical trial.
After about five months of treatments, she was declared cancer-free on Feb. 21, her 34th birthday.
Researchers at AdventHealth of Central Florida, a branch of the nonprofit hospital network headquartered in Altamonte Springs, continue to enroll patients in the region. The phase 3 trial, sponsored by a global pharmaceutical company, aims to test a total of 1,075 patients around the world before it concludes in 2027 or earlier.
Meanwhile, a medical oncologist and hematologist, Dr. Wassim McHayleh, and his team at AdventHealth continue to monitor Rivera-Rollins’ condition.
“I cannot be more thankful to Dr. McHayleh and his team for the care that they have for me,” says Rivera- Rollins, a sixth-grade teacher whose family runs Papa Diesel’s BBQ in Apopka. “I don't know if I could have gone through this journey without the team support.”
The drug being tested in the trial, datopotamab deruxtecan, is among the latest group of cancer-fighting drugs called antibody-drug conjugates. Researchers hope it will set a new standard of care in the future. The drug delivers a dose of chemo that is about eight times more powerful than its traditional counterpart while avoiding its worst side effects because it targets the cancer directly.
“This makes it safer and way more effective,” explains McHayleh, clinical program director for the Breast Cancer Program at AdventHealth Cancer Institute.
About one-third of TNBC patients will still have a residual tumor after traditional treatments are exhausted. At that point, researchers may use the new medication in combination with an immunotherapy drug. It carries its load of chemo intravenously like a Trojan horse inside the tumor cell where the medicine is released, destroying it.
The trial's patients are randomized across three groups. One receives the new drug in combination with immunotherapy. A second receives the new drug alone. A third arm of the trial gets the investigator’s choice of treatments.
TNBC accounts for roughly 15% of breast cancers, the American Cancer Society says. It's more likely to come back after treatment than other forms of breast cancer and is more common in Black women and in women under age 40.
After her diagnosis in October 2022, Rivera-Rollins underwent traditional chemo, immunotherapy, surgery and radiation. Her co-workers, friends and family — including her husband and two children — proved to be a remarkable support group. But she experienced nausea, extreme fatigue and hair loss. Her tumor shrunk but was not eliminated.
Then McHayleh encouraged her to participate in the drug trial. After praying about it, she agreed.
“I was very proud of her when she agreed to participate in the research,” McHayleh says, adding that it can be a challenge to enroll patients from minority backgrounds in medical studies.
Rivera-Rollins is Puerto Rican. Medical trials suffer historically from a lack of diversity, in part because minority patients have been excluded or are wary of volunteering due to past mistreatment.