Clinical Trial: Phase IIB Neoadjuvant Enzalutamide (ZT) Plus Taxol for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer (AR+ TNBC)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase IIB Study of Neoadjuvant Enzalutamide (ZT) Regimen Therapy in Combination With Weekly Paclitaxel for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer

Brief Summary: The goal of this clinical research study is to learn if a combination of enzalutamide and paclitaxel can help to control triple-negative breast cancer (TNBC) by shrinking the tumors in the breast and/or lymph nodes before they are surgically removed. The safety of this treatment combination will also be studied.

Detailed Summary:

Study Drug Administration:

If you are found eligible to take part in this study, you will take enzalutamide by mouth every day for 12 study cycles. Each cycle is 7 days (1 week).

On Day 1 of each cycle, you will receive paclitaxel by vein over about 2 hours.

If you have side effects, the study doctor may decide to lower your study drug dose level or have you stop taking the drug for a short time. If your dosing is stopped, you may be able to restart the study drug later at the same dose or a lower dose. The study doctor will discuss this with you.

Study Visits:

Before treatment begins, blood (about 2 teaspoons) will be collected for biomarker testing (including genetic biomarkers). Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

On Day 1 of each cycle:

  • You will have a physical exam.
  • Blood (about 2 teaspoons) will be drawn for routine tests.

On Day 1 of Cycle 7, blood (about 2 teaspoons) will be drawn for CTC and biomarker tests.

Any time during the 12 study cycles, you may have imaging scans (the same ones that were performed at Screening) to check the status of the disease, if the doctor thinks they are needed.

At the end of 12 cycles:

  • You will have a physical exam.
  • Blood (about 4 teaspoons) wil
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome:

    • Pathologic Complete Response (pCR) of Participants with Triple Negative Breast Cancer (TNBC) [ Time Frame: 84 days ]
      At the end of 12 cycles, imaging scans of the breast and lymph nodes performed to check the status of the disease. Treatment worthy of further study if at least 4 of the 37 patients with pCR.
    • Minimal Residual Disease (RCB-I) of Participants with Triple Negative Breast Cancer (TNBC) [ Time Frame: 84 days ]
      At the end of 12 cycles, imaging scans of the breast and lymph nodes performed to check the status of the disease. Treatment worthy of further study if at least 4 of the 37 patients with RCB-I.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Progression Free Survival (PFS) of Participants with Triple Negative Breast Cancer (TNBC) [ Time Frame: 84 days ]

    PFS defined as the time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first.


    Original Secondary Outcome: Same as current

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: February 12, 2016
    Date Started: September 2016
    Date Completion: September 2020
    Last Updated: April 12, 2017
    Last Verified: April 2017