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

Recruiting Phase 2 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
297 (estimated)
Sponsor
Kristina A. Fanucci · Other
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About This Trial
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 abema…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer. ER and HER2 measurements should be performed according to institutional guidelines in a CLIA-approved…
Contacts

Kristina Fanucci, MD, MHS

617-632-3800

Kristina_Fanucci@dfci.harvard.edu

CONTACT