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Anti-microtubule agent

Abraxane + Mifepristone for Advanced Breast Cancer

Phase 2

Waitlist Available

Led By Rita Nanda, M.D.

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females of child-bearing potential must commit to abstinence from heterosexual contact or agree to use effective contraception

Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to mifepristone or paclitaxel/nab-paclitaxel

Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Summary

This trial is testing whether the addition of the drug mifepristone to nab-paclitaxel improves outcomes for patients with advanced breast cancer that is positive for the glucocorticoid receptor, and negative for estrogen and progesterone receptors.

Who is the study for?

This trial is for adults with advanced triple-negative breast cancer that's glucocorticoid receptor-positive. They can have had some prior treatments but must be in good enough health to participate, not pregnant or breastfeeding, and willing to use contraception. People with active infections, heart issues, certain mental health conditions, or those who've recently had other treatments are excluded.

What is being tested?

The study tests if adding Mifepristone to the chemotherapy drug Nab-Paclitaxel improves outcomes for patients with a specific type of breast cancer. Participants will either receive Mifepristone or a placebo alongside Nab-Paclitaxel and will be monitored over a year after treatment completion.

What are the potential side effects?

Possible side effects include reactions related to the immune system due to Mifepristone, as well as typical chemotherapy-related issues like nerve damage (neuropathy), fatigue, digestive problems from Nab-Paclitaxel.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am committed to not having sex or using birth control if I can have children.

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I am a man who will not have sex or will use a condom with women who can get pregnant.

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I have mild or no nerve damage in my hands and feet.

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My breast cancer is not driven by estrogen, progesterone, or HER2.

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My tumor is positive for the glucocorticoid receptor and I have tissue samples available.

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I am 18 years old or older.

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I can take care of myself but may not be able to do heavy physical work.

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My organ and bone marrow functions are normal.

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My breast cancer is at stage IV or is an unresectable stage III.

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I have at least one tumor that can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to medications similar to mifepristone or paclitaxel.

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I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.

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I have another active cancer besides non-melanoma skin cancer.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am HIV-positive and on combination antiretroviral therapy.

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I have not used corticosteroids for a long time nor am I using them now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS)

Secondary study objectives

Overall Survival

Response Rate

Response Rate in Glucocorticoid Receptor (GR) Positivity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Nab-Paclitaxel+MifepristoneExperimental Treatment2 Interventions

Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)

Group II: Nab-Paclitaxel+PlaceboPlacebo Group2 Interventions

Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-Paclitaxel

2014

Completed Phase 3

~4540

Mifepristone

2013