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Study of Pembrolizumab and Mifepristone in Patients With Advanced HER2-negative Breast Cancer

NCT03225547 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-12-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200mg will be administered to all patients on day 1 of every 21 day cycle.

DRUG

Mifepristone

Mifepristone 300mg will be administered to all patients daily starting the week prior to pembrolizumab.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Rita Nanda, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03225547 on ClinicalTrials.gov