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Invasive Breast CarcinomaPhase 2NCT02689427

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

A Phase 2 study testing Axillary Lymph Node Dissection, Enzalutamide and Laboratory Biomarker Analysis in people with Invasive Breast Carcinoma and Stage I Breast Cancer AJCC v7, run by M.D. Anderson Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axillary Lymph Node Dissection, Enzalutamide and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
22 Sep 2016to 15 Nov 2023
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Patients with histologically confirmed intact primary cancer that is confirmed invasive carcinoma of the breast, with at least 1.0 cm residual disease as measured by mammography, ultrasound, or breast MRI after neoadjuvant anthracycline based chemotherapy.
  • Triple-negative breast cancer defined as ER<10%; PR<10% by immunohistochemistry (IHC) and HER2 0-1+ by IHC, or 2+ FISH non-amplified.
  • Androgen Receptor will be quantified using CLIA-compliant assays for AR on a biopsy specimen obtained prior to initiation of treatment.. AR-positivity is defined as > 10% of nuclear staining.
  • AJCC 7th edition stage I-III Breast Cancer
  • Men or women 18 years of age or older.
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  • Patients must have a performance status of (0-1) on the ECOG performance scale
  • Negative serum or urine pregnancy test must be done within 72 hours before the first dose of the study medication for women of childbearing potential as per institutional guidelines. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy test.
  • Men on study must use a condom if having sex with a pregnant woman.
  • Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration
  • Patient must have adequate organ function as determined by the following laboratory values:
  • Absolute neutrophil count ≥ 1,500 /μL
  • Platelets ≥ 100,000 / μL
  • Hemoglobin ≥ 9 g/dL
  • Creatinine Clearance > 50 ml/min
  • Total Bilirubin < 1.5 x ULN
  • ALT/AST < 2.5 x ULN

Who cannot join

  • Patients who have received any previous antitumor therapies (other than anthracyclinebased neoadjuvant chemotherapy for the current cancer event).
  • Female patients must not be breast-feeding at screening or planning to become pregnant during the course of therapy.
  • Patients having major surgery within 21 days before Cycle 1, Day 1.
  • Patients with known history of hypersensitivity to paclitaxel that did not resolve with pre- medication.
  • Patients with left ventricular ejection fraction <50% or 10% decrease from baseline on echocardiogram after anthracycline based chemotherapy.
  • Patients with gastrointestinal impairment that would affect the absorption of Enzalutamide; or previous history of colitis.
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  • Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy.
  • Patients with known or suspected brain metastasis or active leptomeningeal disease.
  • History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit.
  • Myocardial infarction within 6 months before starting therapy, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • MD Anderson West Houston

    Houston, Texas, 77079

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the pathologic complete response (pCR) and residual cancer burden-index (RCB-I) rates of patients with triple-negative breast cancer (TNBC) who were non-responders to initial anthracycline and cyclophosphamide chemotherapy and who were treated with enzalutamide in combination with weekly paclitaxel in the neoadjuvant setting.

SECONDARY OBJECTIVES:

  1. To estimate progression free survival (PFS) distribution of androgen receptor (AR)-positive TNBC patients who were nonresponders to initial anthracycline and cyclophosphamide chemotherapy, treated with enzalutamide in combination with weekly paclitaxel in the neoadjuvant setting.

II. To determine the safety of administering enzalutamide in combination with weekly paclitaxel in the neoadjuvant setting.

EXPLORATORY OBJECTIVES:

  1. To investigate the association between biomarkers in the peripheral blood and tumor tissue with safety and efficacy for TNBC patients who were treated with enzalutamide and treatment in combination with weekly paclitaxel in the neoadjuvant setting.

II. To investigate the correlation between circulating tumor cells (CTC) characteristics and/or gene profiles and treatment response of enzalutamide and taxane.

OUTLINE:

Patients receive enzalutamide orally (PO) daily on days 1-7 and paclitaxel intravenously (IV) over 2 hours on day 1. Treatments repeat every 7 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.

SURGERY: After 12 cycles of therapy, patients undergo surgical resection of primary tumor with or without lymph node biopsy or complete axillary dissection.

After completion of study treatment, patients are followed up within 30 days after surgery.

Being tested
Axillary Lymph Node Dissection, Enzalutamide, Laboratory Biomarker Analysis, Lymph Node Biopsy, Paclitaxel
Keywords
Androgen Receptor positive TNBC
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary Lymph Node DissectionProcedure or surgery

    Also called ALND, Axillary Dissection, Axillary Lymphadenectomy, Axillary Node Dissection

    Undergo axillary lymph node dissection

  • EnzalutamideDrug

    Also called ASP9785, MDV3100, Xtandi

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Lymph Node BiopsyProcedure or surgery

    Also called Biopsy of Lymph Node

    Undergo lymph node biopsy

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Therapeutic Conventional SurgeryProcedure or surgery

    Undergo surgical resection of primary tumor

Study groups in NCT02689427
Study groupRoleWhat they receive
Treatment (enzalutamide, paclitaxel)ExperimentalPatients receive enzalutamide PO daily on days 1-7 and paclitaxel IV over 2 hours on day 1. Treatments repeat every 7 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: After 12 cycles of therapy, patients undergo surgical resection of primary tumor with or without lymph node biopsy or complete axillary dissection.
Receives: Procedure: Axillary Lymph Node Dissection; Drug: Enzalutamide; Other: Laboratory Biomarker Analysis; Procedure: Lymph Node Biopsy; Drug: Paclitaxel; Procedure: Therapeutic Conventional Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RCB Status

    The RCB (Residual Cancer Burden) is a continuous variable derived from the primary tumor dimensions, cellularity of the tumor bed, and axillary nodal burden. RCB can be divided into four classes (RCB-0 to RCB-III) and will be collected as part of the study. RCB-0 (pCR), Minimal RCB (RCB-I), Moderate RCB (RCB-II), and Extensive RCB (RCB-III)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2016 (estimated)
  2. Study start22 Sep 2016
  3. Primary completion15 Nov 2023
  4. Study completion15 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02689427
Sponsor's protocol ID
2015-0488
Other IDs
NCI-2016-00367, 2015-0488
Status last verified
Apr 2026
First submitted
12 Feb 2016
Last updated
12 May 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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