drugset / Trial / NCT07222215
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)
Phase 2
Recruiting
297 enrolled
Kristina A. Fanucci
Gateway for Cancer Research · collabJohns Hopkins University · collabMenarini Group · collabStemline Therapeutics, Inc. · collabTerri Brodeur Breast Cancer Foundation · collabTranslational Breast Cancer Research Consortium · collab
RandomizedSequentialOpen-labelTreatment
Summary
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)
Timeline
- Start
- 2026-01-16
- Primary completion
- 2029-12-01
- Completion
- 2030-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | Oral |
| Subject | Elacestrant | Other / unclassified | — | Oral |