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

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)

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• 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
• Breast Neoplasms

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Kristina A. Fanucci

Last updated on ClinicalTrials.gov

August 26, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites