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COMPLETED
NCT02689427
PHASE2

Enzalutamide and Paclitaxel Before Surgery in Treating Patients With Stage I-III Androgen Receptor-Positive Triple-Negative Breast Cancer

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase IIB trial studies how well enzalutamide and paclitaxel before surgery works in treating patients with stage I-III androgen receptor-positive triple-negative breast cancer. Androgens can cause the growth of triple-negative breast cancer. Anti-hormone therapy, such as enzalutamide, prevent androgen from binding to the androgen receptor, thereby decreasing cell growth and causing tumor cell death. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving enzalutamide and paclitaxel before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This treatment study is part of the MD Anderson Moonshot initiative.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2016-09-22

Completion Date

2023-11-15

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

PROCEDURE

Axillary Lymph Node Dissection

Undergo axillary lymph node dissection

DRUG

Enzalutamide

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Lymph Node Biopsy

Undergo lymph node biopsy

DRUG

Paclitaxel

Given IV

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgical resection of primary tumor

Locations (2)

M D Anderson Cancer Center

Houston, Texas, United States

MD Anderson West Houston

Houston, Texas, United States