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Clinical Trial Details

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Brief Title Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer
Official Title Phase II Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer
Principal Investigator Nanda, Rita
Brief Summary This is a Phase II study of pembrolizumab plus mifepristone in advanced breast cancer patients. The study will include a safety lead in of ten patients. Patients who are deemed eligible and have signed informed consent will be treated with pembrolizumab at a fixed dose of 200 mg intravenously on day 1 of each 21 day cycle for each dose level. Mifepristone 300mg PO be administered daily starting the week prior to pembrolizumab. Once the safety of the combination is confirmed (study will be paused at least 6 weeks after first 10 patients are enrolled for safety evaluation), dose expansion cohorts will be performed in parallel for two cohorts: cohort 1 in triple-negative breast cancer and cohort 2 in hormone receptor positive breast cancer.
Gender All
Ages 18 Years
Enrollment 74
Accepts Healthy Volunteers No
Lead Sponsor University of ChicagoOther
Collaborator
Study Design
Study Phase Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Advanced HER2-negative Breast Cancer
Detail for Health Professional (on clinicaltrials.gov)
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