MedTrace Logo

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

NCT07222215 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 297

Last updated 2026-01-22

No results posted yet for this study

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)

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
  • Breast Neoplasms

Interventions

DRUG

Capecitabine

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

DRUG

Elacestrant

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

Sponsors & Collaborators

  • Stemline Therapeutics, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    collaborator OTHER

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Menarini Group

    collaborator INDUSTRY

  • Kristina A. Fanucci

    lead OTHER

Principal Investigators

  • Kristina Fanucci, MD, MHS · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2029-12-01
Completion
2030-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07222215 on ClinicalTrials.gov