Pembrolizumab for Breast Cancer

University of Chicago, Chicago, IL
Breast Cancer+1 More ConditionsPembrolizumab - Drug
All Sexes
What conditions do you have?

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

1 of 3
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

2 of 3
This is further along than 68% of similar trials

Side Effects for

Pembrolizumab Second Course
100%Inappropriate antidiuretic hormone secretion
100%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03066778) in the Pembrolizumab Second Course ARM group. Side effects include: Inappropriate antidiuretic hormone secretion with 100%, Urinary tract infection with 100%, Parkinsonism with 100%.

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
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
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

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Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
University of Chicago100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%