A New Era of Hope for Black Patients with Breast Cancer
Tarah Ballinger, MD, and Bryan Schneider, MD, IU Simon Comprehensive Cancer Center
Chemotherapy type can be personalized to decrease harmful side effects for Black patients with breast cancer.
Researchers at the Vera Bradley Foundation Center for Breast Cancer Research at the IU School of Medicine have discovered that Black patients with breast cancer who are treated with a chemotherapy called docetaxel experience less of a harmful side effect called peripheral neuropathy.
Their findings represent an important shift in knowledge about a patient population who’ve historically been underrepresented in breast cancer research.
Taxane-based chemotherapies are the primary curative therapy for breast cancer, but they can lead to taxane-induced peripheral neuropathy (TIPN). Neuropathy symptoms include numbness, tingling, and pain in the hands and feet, which can become debilitating and impact the ability to deliver planned doses of curative chemotherapy.
Researchers are now working to identify trace fragments in the bloodstream that can point to cancers that otherwise would remain hidden. They are looking at why Black women tend to have more aggressive breast cancers. They are studying why some women are more likely to see their cancer recur after initial treatments. And, with the support of the Vera Bradley Foundation, Indiana University is tailoring treatments to each patient.
Results of the clinical study EAZ171, led by Dr. Bryan Schneider, MD, Vera Bradley Professor of Oncology at the IU School of Medicine, found that patients with breast cancer treated with docetaxel every three weeks had less TIPN and fewer dose reductions compared to those who received weekly doses of the chemotherapy paclitaxel.
“Given the disparities that we see with Black patients in terms of survival and toxicity, we felt compelled to address this head-on and design a clinical trial built specifically for this population so that we could try to better personalize our medications and try to improve outcomes in all ways,” said Schneider, who led the clinical trial.
The results were presented by Tarah J. Ballinger, MD, Vera Bradley Foundation Scholar in Breast Cancer Research at the IU Simon Comprehensive Cancer Center, at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago.
“Black women have much higher rates of neuropathy, and that neuropathy tends to be more severe and more impactful. We're seeing more dose reductions in Black women and ultimately reduced survival because of this,” Ballinger said. “Our goal was to specifically focus on Black women for whom this toxicity is more serious and more impactful, and to find ways to intervene specifically for Black patients.”
Notably, the study is among the first National Cancer Institute cooperative group trials to focus enrollment solely on a minority population that has disparate outcomes. The trial enrolled only Black or African American women.
“That's really important because in previous trials, Black women have been underrepresented so our standard of care is based on women who are not Black,” Ballinger said. “We know that Black women have a different disease biology, they have different risk factors, they respond differently to chemotherapy, and they have higher rates of neuropathy. Now we have this whole data set that applies specifically to those patients. We were able to do that because of a lot of involvement from Black women and Black patient advocates.”
Researchers collaborated with Black patient advocates in the trial design and patient recruitment. Focus groups helped inform the study’s design, recruitment, and educational materials.
“This study is critically important,” said Lisa Hayes, Pink-4-Ever Executive Director. “It will improve treatment and hopefully improve breast cancer outcomes for other Black women.”
The clinical study enrolled 249 Black patients with 121 receiving at least one dose of paclitaxel and 118 receiving one dose of docetaxel. The severity of side effects was graded on a scale of one to four, with four being the most severe and life-altering. Grade 2-4 peripheral neuropathy was significantly higher in patients receiving paclitaxel than those receiving docetaxel as reported by both physicians (44% vs. 29%) and patients (40% vs. 24%). Patients receiving paclitaxel required more dose reductions due to peripheral neuropathy (28% vs. 9%) or due to any cause (39% vs. 25%) compared to patients receiving docetaxel.
The study also sought to determine if two inherited gene alterations predicted which patients would have less peripheral neuropathy. While inherited gene alterations were more common in patients who developed TIPN, the data was not statistically significant.
“This study is really exciting because it shows us that we can do better in terms of designing and delivering research trials that ask questions that are important and necessary for underrepresented populations.”
“This starts us down a whole line of research where we stop just describing that there's a disparity in breast cancer outcomes, and we actually start to change our practice so that we're intervening on it,” Ballinger said.”
This study was built on more than a decade of research at the IU Simon Comprehensive Cancer Center. In addition, it drew from the results of a previous clinical trial, E5103, a 5,000-patient, NCI-sponsored study led by Kathy Miller, MD, associate director of clinical research at the cancer center and the Ballvé Lantero Professor of Oncology at IU School of Medicine.
The study laid the groundwork for Schneider’s research to determine the association of genetics with treatment efficacy and chemotherapy-induced toxicities. While performing an analysis, his research team discovered that Black women with breast cancer had a higher risk of developing neuropathy as a side effect of chemotherapy.