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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.
Must not have
HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pembrolizumab and/or mifepristone. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Has a known human immunodeficiency virus (HIV), known active Hepatitis B (e.g. HBsAg reactive), or Hepatitis C (e.g. HCV RNA [qualitative] is detected) infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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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My breast cancer is advanced and cannot be removed with surgery.
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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not HIV-positive or not on antiretroviral therapy.
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I do not have HIV, active Hepatitis B, or Hepatitis C.
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I have or had lung inflammation not caused by infection, treated with steroids.
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I am currently receiving IV treatment for an infection.
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I have recovered from previous cancer treatments and haven't had radiation in the last 3 months.
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I am not pregnant, as the study medication can cause birth defects.
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I have not needed systemic treatment for an autoimmune disease in the last 2 years.
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I have not received a live vaccine in the last 30 days.
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I have cancer that has spread to my brain or surrounding membranes.
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I have been treated with specific immune therapy or mifepristone before.
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I have lung inflammation not caused by an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of overall response based on RECIST 1.1
Secondary study objectives
Number of patients with adverse events
Rate of overall response based on irRECIST

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810
Mifepristone
2013
Completed Phase 4
~3080

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,053 Previous Clinical Trials
759,000 Total Patients Enrolled
25 Trials studying Breast Cancer
4,685 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

Mifepristone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03225547 — Phase 2
Breast Cancer Research Study Groups: Cohort 1, Cohort 2
Breast Cancer Clinical Trial 2023: Mifepristone Highlights & Side Effects. Trial Name: NCT03225547 — Phase 2
Mifepristone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03225547 — Phase 2
~7 spots leftby Sep 2025