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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

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

Mifepristone

2013

Completed Phase 4

~3080

Nab-Paclitaxel

2014

Completed Phase 3

~4340

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,762 Total Patients Enrolled

25 Trials studying Breast Cancer

4,730 Patients Enrolled for Breast Cancer

Rita Nanda, M.D.Principal InvestigatorUniversity of Chicago

Media Library

Nab-Paclitaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT02788981 — Phase 2

Breast Cancer Research Study Groups: Nab-Paclitaxel+Mifepristone, Nab-Paclitaxel+Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there many different sites running this study in the state?

"There are 5 sites currently enrolling for this clinical trial, University of Alabama - Birmingham in Birmingham, University of Chicago in Chicago, and Northshore University HealthSystem in Evanston being a few."

Answered by AI

Is there a potential for serious harm with Mifepristone?

"While there is some data supporting Mifepristone's safety, it did not receive a higher score because Phase 2 trials lack evidence of efficacy."

Answered by AI

Are there any remaining opportunities for individuals to participate in this research?

"This clinical trial is not currently recruiting patients, as indicated on clinicaltrials.gov. The study was first posted on March 28, 2017 and last updated on March 14, 2022. Although this particular trial is no longer looking for patients, there are 3646 other active trials that are currently recruiting patients."

Answered by AI

How many patients are being given this opportunity to participate in the trial?

"Unfortunately, this study has already wrapped up recruitment. The trial was originally posted on March 28th 2017 but was last edited on March 14th 2022. However, there are presently 2764 clinical trials actively admitting patients with breast cancer and 882 studies for Mifepristone actively admitting participants."

Answered by AI

What other scientific studies have looked into Mifepristone's effects?

"City of Hope Comprehensive Cancer Center first looked into mifepristone in 1997 and since then, 19458 studies have been completed with 882 more currently ongoing. A large number of these active trials originate from Birmingham, Alabama."

Answered by AI

For what conditions is Mifepristone typically prescribed?

"Mifepristone is most frequently used as a treatment for non-small cell lung carcinoma, but it can also be prescribed to patients with neoplasm metastasis, kaposi sarcoma, and other conditions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer

2017. "Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02788981.

All > Metastatic Triple Negative Breast Cancer > Paid Studies Wisconsin