PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4/6 inhibitors, including palbociclib, ribociclib, or abemaciclb. The names of the study drugs involved in this study are: * Elacestrant (a type of selective estrogen receptor degrader) * Capecitabine (a type of fluoropyrimidine antimetabolite)

NCT Number	NCT07222215
Lead Sponsor	Kristina A. Fanucci Collaborators: Stemline Therapeutics, Inc., Johns Hopkins University, Translational Breast Cancer Research Consortium, Menarini Group, Gateway for Cancer Research, Terri Brodeur Breast Cancer Foundation
Conditions	Estrogen-receptor-positive Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, HER2- Breast Cancer, ESR1 Gene Mutation, ER Wildtype +1 more
Enrollment	297 participants
Start Date	2026-01-16
Primary Completion	2029-12-01 (estimated)
Study Completion	2030-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-12