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Hormone Therapy
Pembrolizumab + Mifepristone for Breast Cancer
Phase 2
Waitlist Available
Led By Rita Nanda, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1.
Age ≥ 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced HER2-negative breast cancer, including those with triple-negative or hormone receptor positive subtypes. Participants must have measurable disease and be in good health otherwise, with normal organ and marrow function. Women should not be pregnant and must use contraception; men also need to agree to use contraception. Patients can't join if they've had certain recent treatments, have specific infections or autoimmune diseases, are on conflicting medications, or have untreated brain metastases.Check my eligibility
What is being tested?
The study tests Pembrolizumab combined with Mifepristone in patients who haven't responded well to other therapies. It starts with a safety check on the first ten patients using Pembrolizumab every three weeks and daily Mifepristone starting one week before that. If safe, more patients will join either of two groups based on their cancer type.See study design
What are the potential side effects?
Possible side effects include immune system reactions affecting organs (like inflammation), fatigue, skin rashes especially after radiation therapy, hormonal changes due to Mifepristone's properties as an abortifacient agent which could affect pregnancy outcomes if applicable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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I am a male and will use protection or abstain from sex with women who can get pregnant during and 6 months after the study.
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I am using effective birth control and have a negative pregnancy test.
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My breast cancer is advanced and cannot be removed with surgery.
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I have triple-negative breast cancer and can join the trial regardless of my previous treatments.
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My breast cancer is ER+ or PR+ and has not responded to at least 2 hormone treatments.
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My cancer can be measured and is larger than specified sizes on scans or exams.
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My blood tests show my organs are functioning well.
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I have had previous treatments for my condition.
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My cancer can be measured by tests or scans.
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My breast cancer is hormone receptor positive.
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My breast cancer is triple negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of overall response based on RECIST 1.1
Secondary outcome measures
Number of patients with adverse events
Rate of overall response based on irRECIST
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment2 Interventions
Enrollment will be paused after the first 10 patients are enrolled in the study for a safety evaluation. Once safety is confirmed, patients with triple-negative advanced breast cancer will be enrolled in cohort 2. Regardless of cohort, all eligible patients will be treated with pembrolizumab (on day 1 of every 21 day cycle), and mifepristone (administered daily starting the week prior to pembrolizumab).
Group II: Cohort 1Experimental Treatment2 Interventions
Enrollment will be paused after the first 10 patients are enrolled in the study for a safety evaluation. Once safety is confirmed, patients with hormone receptor positive, hormone refractory advanced breast cancer will be enrolled in cohort 1. Regardless of cohort, all eligible patients will be treated with pembrolizumab (on day 1 of every 21 day cycle), and mifepristone (administered daily starting the week prior to pembrolizumab).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Mifepristone
2013
Completed Phase 4
~3080
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
996 Previous Clinical Trials
816,624 Total Patients Enrolled
24 Trials studying Breast Cancer
4,611 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I am 18 years old or older.I am a male and will use protection or abstain from sex with women who can get pregnant during and 6 months after the study.You have had allergic reactions to drugs that are similar to pembrolizumab or mifepristone.I am not HIV-positive or not on antiretroviral therapy.I do not have HIV, active Hepatitis B, or Hepatitis C.I am not taking NSAIDs or warfarin, or understand the risk of increased drug levels.I am currently receiving IV treatment for an infection.I have recovered from previous cancer treatments and haven't had radiation in the last 3 months.My breast cancer is advanced and cannot be removed with surgery.I have triple-negative breast cancer and can join the trial regardless of my previous treatments.My breast cancer is ER+ or PR+ and has not responded to at least 2 hormone treatments.I have another cancer besides the one being studied, but it's not getting worse or needing treatment.I have not been in a clinical trial for a new treatment or device in the last 4 weeks.I have cancer that has spread to my brain or surrounding membranes.I have had previous treatments for my condition.My cancer can be measured by tests or scans.My breast cancer is hormone receptor positive.I am not pregnant, as the study medication can cause birth defects.I understand my medication levels may change with mifepristone.I have or had lung inflammation not caused by infection, treated with steroids.I have not needed systemic treatment for an autoimmune disease in the last 2 years.I have not received a live vaccine in the last 30 days.I use corticosteroids regularly, not just for premedication or supportive care.I am using effective birth control and have a negative pregnancy test.My cancer can be measured and is larger than specified sizes on scans or exams.My blood tests show my organs are functioning well.I have been treated with specific immune therapy or mifepristone before.I have lung inflammation not caused by an infection.My breast cancer is triple negative.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
University of Chicago
What portion of applicants met pre-screening criteria?
Did not meet criteria
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