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Spotlight on Clinical Trials: Shining a Light on Breast Cancer Disparities

“In the Black community, there’s a stigma about treatment, clinical trials and research. We have to understand that there’s not enough data to help us if we get sick. There’s not enough data to create treatments that will help us. We need to participate in clinical trials.” Sharon Elmore-Anderson Patient Advocate Living with Metastatic IBC 

Clinical trials are the way that breast cancer researchers determine how well a new approach, such as a new drug or medical device, is safe or effective for use in people. Unfortunately, there are some disparities when it comes to diversity in breast cancer clinical trials. For clinical trials to benefit all people in the breast cancer community, they must include participants who represent everyone that gets breast cancer. 

This is even more challenging for Black women, who already face several barriers including systemic racism and below-standard care. Black women in the U.S. are also dying from breast cancer at a 40% higher rate than white women and this rate is as high as 74% in some communities. While these numbers prove the Black community needs to be involved in research, an analysis from 2020 shows that out of 32,000 participants in clinical trials, only 8% were Black.  

“When we see a lot of the examples and findings from clinical trials, they really are only a function of those who participate, which is often not enough Black patients,” Bryan Schneider, M.D., says. “So, we’re globally making decisions based on patients of other races who we know have different outcomes.”  

Connecting Treatment Side Effects to Race and Disparities 

Researchers like Dr. Schneider are changing the research landscape through studies that focus on disparities in treatment outcomes for Black women, like the EAZ171 clinical trial. Dr. Schneider, who is leading the EAZ171 trial, is director of the Indiana University Health Precision Genomics Program and a professor of medicine and medical/molecular genetics at the IU Melvin and Bren Simon Comprehensive Cancer Center. 

Prior to his work on the EAZ171 trial, with funding from Komen, Dr. Schneider discovered Black cancer patients have an increased risk of a side effect called taxane-induced peripheral neuropathy (TIPN), which comes from some chemotherapy drugs. This neuropathy, or inflammation of the nerves, causes symptoms including numbness, tingling, pain and/or muscle weakness in the hands and feet.  

“We were able to define that Black patients got more neuropathy,” Dr. Schneider says. “We were also able to further identify some genetic variations that put patients of African descent at an even a higher risk. This body of work led to the EAZ171 clinical trial.” 

EAZ171 Clinical Trial 

The EAZ171 clinical trial is one of the first-ever cooperative group studies to focus on Black breast cancer patients. In this study, Dr. Schneider and his team are using a simple blood test to identify biomarkers, or molecules in the blood, that show which women are most at risk for TIPN. Next, they are studying which of two chemotherapy drugs, docetaxel or paclitaxel, results in less side effects that cause neuropathy. 

“EAZ171 [uses] DNA biomarkers to try to better predict which patients will get neuropathy and will help to personalize the best therapy for each patient,” says Dr. Schneider. “This sets us up to think about developing drugs to either treat or prevent this side effect from ever happening, which would be an amazing next step.” 

Why is this Study So Important? 

The EAZ171 trial addresses how a treatment may affect a patient’s quality of life, as well as survival. Painful side effects like TIPN can impact whether a patient follows their recommended treatment plan. For those who experience these side effects, it is often necessary to either lower the dose of chemotherapy or stop treatment altogether to prevent severe and irreversible damage which can impact quality of life. However, lowering the dose this can lead to even worse outcomes for Black women, who are already dying at a higher rate from breast cancer than white women. 

Through EAZ171, Dr. Schneider and his team are engaging and actively recruiting members of the Black community to take part in this study. Rebuilding trust between the medical field and the Black community is crucial, considering the historical and systemic injustices towards the Black community.  

Because of this, it is important that researchers establish open lines of communication and transparency with the Black community and include trusted community partners like local churches. Through EAZ171, Dr. Schneider learned that the members of the community he reached out to did want to be part of research that would make a difference. 

“It was really critical they wanted to be part of this, and for me it still remains a learning experience,” Dr. Schneider says. “It is a great experience and a journey that I hope we get better at as we move forward.” 

Visit our clinical trials page to learn more about clinical trials and read about our featured clinical trials.  

Did you know? Komen has invested nearly $140 million in over 320 research grants and nearly 190 clinical trials focused on breast cancer disparities & inequities.