CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Enzalutamide +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02689427
NCT02689427Phase 2Completed

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

M.D. Anderson Cancer Center·interventional·Posted Feb 24, 2016·Updated May 12, 2026

In Brief

A Phase 2 clinical trial evaluating Axillary Lymph Node Dissection, Enzalutamide, and 4 other interventions for Invasive Breast Carcinoma and 11 related conditions. Completed, enrolled 24 participants across 2 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 24, 2016
Enrollment StartSep 22, 2016
Primary CompletionNov 15, 2023
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 10.4 years ago

Interventions

Axillary Lymph Node Dissectionprocedure

Undergo axillary lymph node dissection

Enzalutamidedrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Lymph Node Biopsyprocedure

Undergo lymph node biopsy

Paclitaxeldrug

Given IV

Therapeutic Conventional Surgeryprocedure

Undergo surgical resection of primary tumor