Why is this study being done?
We hope to improve outcomes for black women with breast cancer. Black women are 41 percent more likely to die from breast cancer than white women. There are two goals in this study:
- To determine which women are most at-risk for this side effect of neuropathy based on their DNA.
- To determine which regularly prescribed chemotherapy treatment, docetaxel or paclitaxel, will result in less of a side effect that causes nerve damage, known as peripheral neuropathy, for black women with breast cancer.
Recent research shows that patients of African ancestry who take chemotherapy drugs such as docetaxel or paclitaxel have a higher risk for neuropathy. Symptoms of this side effect most often appear in the hands and feet and include:
- Numbness, tingling, and pain
- Muscle weakness
- Sensitivity to temperature
These symptoms are collectively called neuropathy. Through this trial, we can identify the better treatment specific to women of African ancestry with breast cancer to reduce neuropathy.
Why is it important for black women to participate?
Because of past wrongs done by researchers and a lack of trials focused on patients of African ancestry, black patients are strikingly under-represented within clinical trials.
As a result, our knowledge of cancer treatments is based mostly on the information gathered from white patients. Our research shows that black patients have a much higher risk of experiencing side effects from chemotherapy, especially neuropathy.
Neuropathy causes doctors to lower or even stop chemotherapy doses in their patients. In turn, breast cancer comes back (recurs) more often in black patients compared with white patients and creates worse survival rates in black people. Neuropathy is painful, can impact quality of life, and is sometimes permanent. The American Society of Clinical Oncology considers neuropathy caused by chemotherapy to be one of the three most important survivorship issues impacting cancer patients.
This study is designed to help figure out why black women experience more neuropathy and which drugs are best at reducing it.
What will happen if I decide to take part in this study?
If your treatment team decides chemotherapy with paclitaxel or docetaxel is right for you and you decide to take part in this study, you will:
- Receive paclitaxel or docetaxel. Both of these drugs are FDA-approved to treat breast cancer. Your doctor may also prescribe other treatments that are routinely used to treat your type of breast cancer.
- Provide a sample of blood for research.
- Answer surveys so researchers can learn more about how the side effects of chemotherapy drugs like docetaxel and paclitaxel affect your life.
After you finish your study treatment, your doctor will continue to follow you for up to five years and check with you for side effects. You will be asked to return six months after you join the study for another optional blood draw.
What are the study groups?
This study has two study groups. Both groups use FDA-approved treatments for your cancer.
- Group 1: If you are in this group, you will get paclitaxel. You will receive this drug through a vein in the arm once a week for 12 weeks. There will be about 120 people in this group.
- Group 2: If you are in this group, you will get docetaxel. You will receive this drug through a vein in the arm once every three weeks for up to 18 weeks. There will be about 120 people in this group.
Talk with your doctor about which group is the right choice for you.