Racial Disparities and Clinical Trials for Metastatic Breast Cancer

Breast cancer is diagnosed more often than any other cancer worldwide. In 2020, there were an estimated 2.3 million new breast cancer cases. In the United States, 6 percent of women have metastatic breast cancer when they are first diagnosed. There are many factors that affect how likely certain groups of people are to develop breast cancer and to survive it. These factors include race, ethnicity, and geographic location.^1,2

The differences in cancer incidence and survival between groups of people are called health disparities. It is important to understand how and why health disparities can affect your health.

What are racial disparities?

The differences in breast cancer outcomes between racial groups are referred to as racial disparities, and they are a cause for concern. For example, according to a 2022 study, Black women have the highest breast cancer death rate of any racial group. They are 40 percent more likely to die from their cancer than white women are.³

Research has shown that Black women also are more often diagnosed with:^1,3

• Larger tumors
• Aggressive types of cancer
• Advanced stage and metastatic cancers

The reasons for worse breast cancer outcomes among Black women are not fully known. The causes need to be studied further, but issues that may contribute include:³

• Lower awareness of the risks and symptoms of breast cancer
• Lack of trust of the healthcare system
• Less access to healthcare
• Increased time to care
• Fear of the stigma around a cancer diagnosis
• Fear of new treatments

How do racial disparities relate to breast cancer clinical trials?

Clinical trial results are used to determine whether new therapies are safe and effective for people to receive. They also affect whether the US Food and Drug Administration (FDA) approves these therapies for use by the general public.³

As scientists study and develop new treatments for breast cancer, the racial differences in clinical trial participation are clear. People of color make up at least 40 percent of the US population, but very few of them are involved in clinical trials. In fact, up to 80 to 90 percent of people who participate in clinical trials are white.³

New therapies for breast cancer are less successful when people of color are not included in clinical trials. One example is research for triple-negative breast cancer (TNBC). TNBC is one of the most aggressive breast cancers and also the least studied.³

TNBC is more common among Black women, but these women are less likely to take part in TNBC clinical trials. Only 6 to 8 percent of people enrolled in TNBC clinical trials before 2022 were Black.³

Equal clinical trial enrollment is essential to find effective treatments with reliable and valid results for all people.³

What can be done to address this problem?

Several factors contribute to the racial disparities in breast cancer rates. Addressing each of these factors can improve health outcomes for people with breast cancer.¹

For example, focusing on the communities that are most at risk of a metastatic breast cancer diagnosis is important. Using culturally appropriate messages to inform and educate people about breast cancer risks and symptoms may lead to higher survival rates. It also may lead to a decrease in the number of people who are diagnosed with late-stage breast cancer.¹

Increasing recruitment and enrollment of people of color for clinical trials is also necessary. Several groups can lead the way in making sure that enrollment focuses on equal inclusion of all races and ethnicities. These groups include:³

• Study sponsors
• Regulatory agencies
• Funding agencies
• Individual researchers

Increasing participation by people of color in clinical trials can help more people survive breast cancer. If you would like to participate in a breast cancer clinical trial, talk to your doctor. You can learn more about how clinical trials work at ClinicalTrials.gov.