Last updated on March 2018

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

Brief description of study

This is a randomized, placebo-controlled, double-blind, phase II trial of nab-paclitaxel with or without mifepristone for advanced, glucocorticoid receptor-positive, triple-negative breast cancer. A total of 64 patients will receive nab-paclitaxel. Patients will be randomly assigned to either receive placebo or to receive mifepristone daily on the day prior to and day of each dose of nab-paclitaxel. Patients will be enrolled over 12 months and followed for 12 months following completion of study.

To expand and follow up on the investigators understanding of a potential pharmacokinetic (PK) interaction between nab-paclitaxel and mifepristone, investigators will perform PK studies in the first 20 patients enrolled at pre-specified "PK sites".

Detailed Study Description

Primary Objective:

To compare the progression free survival (PFS) of patients treated with nab-paclitaxel + placebo and patients treated with nab-paclitaxel + mifepristone.

Secondary Objectives:

  1. To correlate percentage glucocorticoid receptor (GR) positivity in the most recent metastatic tumor biopsy (or in primary tumor if only primary tumor is available) with PFS in mifepristone and placebo groups.
  2. To perform an exploratory assessment of overall response rate in both groups.
  3. To collect information regarding overall survival in both treatment cohorts.

Clinical Study Identifier: NCT02788981

Contact Investigators or Research Sites near you

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Gini Fleming, M.D.

University of Chicago
Chicago, IL United States
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Erica Reasor, MD

University of Alabama - Birmingham
Birmingham, AL United States
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Recruitment Status: Open

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