RecruitingPhase 2NCT07222215

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

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)


Sponsor

Kristina A. Fanucci

Enrollment

297 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (CAPELA) is testing whether adding a hormone-blocking drug called elacestrant to the chemotherapy capecitabine works better than capecitabine alone in people with estrogen receptor-positive, HER2-negative advanced breast cancer who also have a specific genetic mutation in the ESR1 gene. **You may be eligible if...** - You have estrogen receptor-positive (ER+), HER2-negative advanced or metastatic breast cancer - Your tumor has been tested and has one of several qualifying ESR1 gene mutations - You are 18 or older - Standard testing confirms your ER and HER2 status **You may NOT be eligible if...** - Your tumor is HER2-positive or ER-negative - You do not have an ESR1 mutation, or your ESR1 testing result is more than 2 months old - You have not received prior hormone therapy (endocrine therapy) for your metastatic disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

A fluoropyrimidine carbamate, tablet taken orally, per standard of care.

DRUGElacestrant

A selective estrogen receptor degrader, tablet taken orally, per standard of care


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07222215


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