A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)
This study is testing if adding a hormone therapy drug called elacestrant to a chemotherapy medication called capecitabine works better than using chemotherapy alone. It is designed for patients whose advanced breast cancer has stopped responding to standard treatments like CDK 4/6 inhibitors.
This study is for adults with advanced hormone receptor-positive, HER2-negative breast cancer. You must have specific gene changes in your tumor (known as ESR1 and TP53 mutations) confirmed by a blood test to be eligible.
Participants will be randomly assigned to receive either the combination of two drugs or just the chemotherapy drug alone. Researchers will then monitor you closely to see how your cancer responds to the treatment and manage any side effects you might experience.
The study is currently recruiting new participants at a location in Boston, Massachusetts. Please speak with your oncologist to see if this trial is a good fit for your specific health situation.
- 1Tests a new combination of hormone therapy and chemotherapy.
- 2Specifically for patients whose cancer progressed after prior CDK 4/6 therapy.
- 3Requires genetic testing of your tumor to confirm eligibility.
- 4Currently recruiting new participants in Boston.
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