Hollings clinical trial gives breast cancer survivor new lease on life

Varnesta Major, 62, has a lot of reasons to live – 21 in fact – four children, 13 grandchildren, and four great-grandchildren, not to mention her extended church family. The Charleston native is already looking forward to celebrating the upcoming holidays with family one year after being diagnosed with stage 2A breast cancer. Major completed treatment and is officially in remission, thanks in part to a clinical trial at MUSC Hollings Cancer Center.

Major, who was diagnosed with breast cancer in early 2020, noticed something wasn’t right after she discovered a lump on her breast during a routine self-examination. She got a mammogram through South Carolina’s Best Chance Network, which eventually led her to Hollings.

“When I found out it was cancer, I was told that I was going to lose the breast. That was devastating. But I tried not to show it and didn’t cry,” Major said. “I made up my mind that I was going to do whatever I needed to because I wanted to live.”

Major’s tumor measured 5.5 centimeters and was hormone positive and human epidermal growth factor receptor 2 (HER2) negative. The diagnosis got the attention of Frank Brescia, M.D., a Hollings’ oncologist and breast cancer specialist. “People think of breast cancer as one disease, and it’s really not,” Brescia said. “The biology is quite different from one patient to the next, which makes more targeted treatment needed as we move forward.”

Brescia is leading a clinical trial at Hollings for hormone positive, HER2 negative breast cancer, testing the effectiveness of Pembrolizumab in combination with eight cycles of chemotherapy treatment before surgery and another nine cycles of chemotherapy after surgery. “Doxorubicin, cyclophosphamide and paclitaxel are our core chemotherapy drugs,” he said. “In this study, we’re asking the question if we give the Pembrolizumab, which enhances T-cells in patients who have a high risk of cancer, will we make a difference?”

Major said taking part in the clinical study at Hollings was a no-brainer. “I wanted to come to MUSC because I trust them. It is a school of learning, and I felt that if I could help someone else along the way by participating in this clinical trial, then that was my purpose.”

Setting the course for more effective breast cancer treatment

Brescia said Pembrolizumab, a type of immunotherapy, is a newer approach to treating breast cancer. Traditionally, immunotherapy had been used to treat diseases like malignant melanoma and lung cancer. But results in some breast cancer patients can’t be ignored, he said. Brescia remembers the first breast cancer patient he treated with Pembrolizumab years ago.

 

“I had a patient with triple negative breast cancer who had tried every treatment possible and had a local recurrence in the breast that was becoming unbearable. It was growing, ulcerating and was very painful. Out of desperation, I used Pembrolizumab, and within two to three months, the cancer had gone away.”

Patients taking part in this clinical trial receive either Pembrolizumab or a placebo during chemotherapy. Brescia said previous research has allowed them to predict which patients may respond best to Pembrolizumab.

“We look for proteins called PDL1 on the T-cells, which play a role in preventing proper immune responses. If the PDL1 receptor markers are on the T-cells, then we have a better prediction of whether this drug is going to work and can enhance the immune response. We are essentially trying to get the body’s T-cells to fight the cancer,” Brescia said.

Brescia said he has been pleased with how well this treatment has been tolerated by patients in the trial. He said the main side effects include colitis, dysfunction of the thyroid and skin rashes.

“You don’t have to make patients terribly sick to get good responses,” Brescia said. “The drugs are becoming so much better and nuanced. Years ago, patients had all kinds of medicine and treatment options thrown at them. Now, there is much more interest in side effects and long-term effects on the patients.”

For Major, the worst side effect of treatment was exhaustion, and in late April 2020, she developed a case of shingles, which forced her to stop the trial for two months.

The bumpy journey was worth it, though, when prior to her surgery in September 2020, doctors gave Major the news she wanted to hear. “They told me the tumor had shrunk a lot,” she said. “To me, that meant the something in this trial was working.”

Brescia said Major’s response to the treatment was the best-case scenario, with her pathological results after surgery showing a complete response. “She had some noninvasive ductal carcinoma in situ, but she is without evidence of disease. That doesn’t mean she is cured, but at this point, we’ve seen no recurrence.”

Serving as an example

Major admits there is hesitancy in the African American community to open up about health care issues and participate in clinical trials. That’s why sharing about her cancer journey is so personal.

 

Major watched as her father died from lung cancer in the early 1990s. She hopes the information researchers gained through her participation in the clinical trial can prevent more lives from being lost to the disease.

“In the African American culture, we don’t want to feel like we are guinea pigs for science,” she said. “But I don’t see it like that. I hope my story changes the conversation in the community because medicine has come such a long way, and a big reason for that is because of clinical trials.”

Brescia said he understands the hesitancy for some to participate in clinical trials and believes that the medical community has an obligation to show communities they will get something in return from their participation. “I see my role as trying to be an advocate for the individual patient, whether they are white, black, green or pink. It makes no difference to me. You need time to earn underserved communities’ trust and prove that you are on their side and want to make a positive difference.”

Major is thankful for the doctors and researchers at Hollings. She finished treatment in May and said she looks forward to spending a lot more time with her biological and religious families. “This clinical trial gave me a second chance at life. I can do things that I otherwise may not have been able to do. I’m excited to live.”

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