Hollings clinical trial to test treatment options for women with triple-negative breast cancer and heart disease

A new clinical trial at MUSC Hollings Cancer Center focuses on finding answers for a group of women who don’t have clear treatment options.

Doctors follow a well-established treatment plan for women with stage 2 or stage 3 triple-negative breast cancer: a combination of five drugs, which shrinks or destroys the tumor in 65% of women, and then surgery.

But women with heart problems can’t take one of the drugs – Adriamycin, or the “red devil” – in the five-drug combination, said breast cancer doctor Abirami Sivapiragasam, M.D., known to her patients as Abi Siva. This leaves doctors on their own to decide on the best treatment.

There are no guidelines that tell you what to do, so most doctors will make their own decisions,” she said. “So some may use three drugs from the five-drug cocktail – carboplatin, paclitaxel and pembrolizumab. Some may use carboplatin, docetaxel and pembrolizumab. Some may opt for 18 weeks of treatment instead of the standard six-month regimen. There really is no standard.”

Siva wants to change that.

Siva, who came to Hollings in 2023 from SUNY Upstate University Hospital in New York, realized that the lack of guidelines was doing a disservice to her new patients. Triple-negative breast cancer is a particularly aggressive form of breast cancer, and it’s about twice as likely to occur in Black women as white women. Many patients, especially from rural areas, are facing multiple serious health problems at the same time as a cancer diagnosis, including heart disease. And cardiac toxicity is a known side effect of certain cancer treatments and is more likely to happen among Black women.

So instead of excluding breast cancer patients with heart problems – which is how most clinical trials are set up – the trial that Siva developed is especially for women with cardiomyopathy, a disease of the heart muscle, and women who are at high risk of developing heart problems because of the cancer drugs.

“This is a real challenge we face in South Carolina, which is why we felt this study would be an important and timely initiative,” she said. 

She’s also bringing the trial out into the community, closer to the people who need it.

"This is a real challenge we face in South Carolina, which is why we felt this study would be an important and timely initiative."

Abirami Sivapiragasam, M.D.

She estimated that she might see six to 10 patients per year in downtown Charleston who would fit the criteria for this trial. But her counterparts in more rural areas see more patients who fit the criteria.

“I think, based on what the providers have said from Florence and Tidelands, they see more patients with this problem than we do,” she said.

For that reason, she’s opening the trial at Tidelands Health in Georgetown County and MUSC Health Florence Medical Center, in addition to Hollings.

Patients in the trial will get two chemotherapy drugs and an immunotherapy drug for 12 weeks. At that point, they’ll get MRI scans to see if the cancer is responding.

“Twelve weeks of treatment may be sufficient for some but not for others,” Siva said. “So, we are assessing the response with an MRI after 12 weeks to see how the cancer has responded. If we see a complete response on MRI, patients can proceed to surgery. However, if residual tumor is still visible on MRI, they will receive an additional six weeks of treatment.”

A complete response means no cancer can be seen on the scan.

“So we are doing a response-adaptive design to tailor the right amount of chemo for the right patient,” she explained. “We could give 18 weeks of chemo to everybody, but that comes with toxicity. We are trying to minimize the toxicity and personalize treatment based on their responses.”

For those women who can take the typical five-drug regimen, about 65% will show a complete response, and they usually have the best long-term outcomes, Siva said.

She hopes that this new clinical trial is the start of finding effective answers for those women who cannot take the five-drug regimen.

The trial is slated to begin enrolling patients this month and is expected to last about eight years.

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