Study Summary
This trial is testing a combination of two drugs to treat advanced breast cancer. The first part of the trial will test the safety of the combination in ten patients. If the combination is safe, the trial will expand to include more patients.
Eligible Conditions
- Triple Negative Breast Cancer
- Breast Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 2
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Up to 3 years
Month 100
Rate of overall response based on RECIST 1.1
Rate of overall response based on irRECIST
Up to 3 years
Number of patients with adverse events
Trial Safety
Phase-Based Safety
This is further along than 68% of similar trials
Side Effects for
Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
100%Parkinsonism
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2 Treatment Groups
Cohort 2
1 of 2
Cohort 1
1 of 2
Experimental Treatment
74 Total Participants · 2 Treatment Groups
Primary Treatment: Pembrolizumab · No Placebo Group · Phase 2
Cohort 2Experimental Group · 2 Interventions: Pembrolizumab, Mifepristone · Intervention Types: Drug, Drug
Cohort 1Experimental Group · 2 Interventions: Pembrolizumab, Mifepristone · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Mifepristone
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Who is running the clinical trial?
University of ChicagoLead Sponsor
948 Previous Clinical Trials
759,922 Total Patients Enrolled
23 Trials studying Breast Cancer
4,636 Patients Enrolled for Breast Cancer
Rita Nanda, MDPrincipal InvestigatorUniversity of Chicago
3 Previous Clinical Trials
48 Total Patients Enrolled
2 Trials studying Breast Cancer
37 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 25 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Illinois | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Chicago | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |