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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

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

~3150

Mifepristone

2013

Completed Phase 4

~3080