Phase IIB Neoadjuvant Enzalutamide (ZT) Plus Taxol for Androgen Receptor (AR)-Positive Triple-Negative Breast Cancer (AR+ TNBC)
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|ClinicalTrials.gov Identifier: NCT02689427|
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : February 1, 2018
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.
This is an investigational study. Paclitaxel is FDA approved and commercially available for the treatment of breast cancer that does not respond to chemotherapy. Enzalutamide is not FDA-approved for breast cancer. It is currently being used for research purposes only in breast cancer patients. The study doctor can explain how these study drugs are designed to work.
Up to 37 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Enzalutamide Drug: Paclitaxel||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: Enzalutamide + Paclitaxel
Participants receive Enzalutamide by mouth every day for 12 study cycles. Each cycle is 7 days (1 week).
On Day 1 of each cycle, participants receive Paclitaxel by vein over about 2 hours.
120 mg by mouth every day for 12 study cycles. Each cycle is 7 days (1 week).
80 mg/m^2 by vein on Day 1 of each 7 day cycle.
Other Name: Taxol
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689427
|Contact: Naoto Ueno, MD, PHD||713-792-2817|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Naoto Ueno, MD, PHD||M.D. Anderson Cancer Center|