Clin2
NCT07222215Possibly a fitRecruiting

Capacitabine with or without elacestrant for ER+ breast cancer

Estrogen-receptor-positive Breast CancerMetastatic Breast CancerBreast CancerHormone Receptor Positive Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastHER2- Breast CancerESR1 Gene MutationER Wildtype

Treatments studied

Part of Cancer, Skin clinical trials.

This trial tests if adding a new oral targeted therapy (elacestrant) to standard chemotherapy (capecitabine) works better than chemotherapy alone for people with a specific type of advanced breast cancer that is hormone-sensitive (ER-positive) and has stopped responding to hormone therapy.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 2
Enrollment
297 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have advanced (metastatic or locally recurrent) breast cancer that is estrogen receptor-positive (ER+) and HER2-negative.
  • You have had at least one prior hormone therapy for advanced disease, or you relapsed during or within a year of finishing adjuvant hormone therapy.
  • You have a specific ESR1 or TP53 gene mutation in your tumor, confirmed by a blood or tissue test.
  • You have not had chemotherapy for advanced breast cancer before (prior hormone therapy and CDK4/6 inhibitors are allowed).
  • You can swallow pills and have adequate organ function (kidney, liver, blood counts).

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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