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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by M.D. Anderson Cancer Center
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: February 12, 2016
Last updated: September 22, 2016
Last verified: September 2016
The goal of this clinical research study is to learn if a combination of enzalutamide and paclitaxel can help to control 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.

Condition Intervention Phase
Breast Cancer
Drug: Enzalutamide
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Pathologic Complete Response (pCR) of Participants with Triple Negative Breast Cancer (TNBC) [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.

Secondary Outcome Measures:
  • Progression Free Survival (PFS) of Participants with Triple Negative Breast Cancer (TNBC) [ Time Frame: 84 days ] [ Designated as safety issue: No ]
    PFS defined as the time from enrollment to progression of disease (> 20% increase in tumor size) or death whichever comes first.

Estimated Enrollment: 37
Study Start Date: September 2016
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Enzalutamide
160 mg by mouth every day for 12 study cycles. Each cycle is 7 days (1 week).
Other Names:
  • MDV3100
Drug: Paclitaxel
80 mg/m^2 by vein on Day 1 of each 7 day cycle.
Other Name: Taxol

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must be willing to sign the protocol-specific written informed consent.
  2. Patients with histologically confirmed intact primary cancer that is confirmed invasive carcinoma of the breast who have at least 1.0 cm of measurable residual disease on imaging by either mammography, ultrasound, or breast MRI after neoadjuvant anthracycline based chemotherapy.
  3. Patients must have triple-negative breast cancer defined as ER<10%; PR<10% by immunohistochemistry (IHC) and HER2 0-1+ by IHC or 2+, FISH non-amplified.
  4. AR will be stained using CLIA-compliant assays for AR with the initial biopsy specimen. AR- positivity is defined as >/= 1% of nuclear staining.
  5. Patient's disease state must be AJCC 7th edition stage I-III.
  6. Men or women must be 18 years of age or older.
  7. Patients must have a performance status of </= to 1 on the ECOG performance scale.
  8. A 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 (defines as no menses for at least 1 year) and surgically sterilized women are not required to undergo pregnancy test.
  9. Men on study must use a condom if having sex with a pregnant woman.
  10. Male patients 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.
  11. Patient must have adequate organ function as determined by the following laboratory values: 1) Absolute neutrophil count >/= to 1,500 /uL 2) Platelets >/= to 100,000 / uL 3) Hemoglobin >/= to 9 g/dL 4) Creatinine clearance >/= to 50 ml/min 5) Total bilirubin </= to 1.5 X ULN 6) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= to 2.5 X ULN.

Exclusion Criteria:

  1. Patients must have not have received any other previous antitumor therapies other than anthracycline-based chemotherapy for the current cancer event.
  2. Female patients must not be breast-feeding at screening or planning to become pregnant during the course of therapy.
  3. Patients must not have had major surgery within 21 days before Cycle 1, Day 1.
  4. Patients must not have a known history of hypersensitivity to paclitaxel that did not resolve with pre- medication.
  5. Patients must not have left ventricular ejection fraction <50% or 10% decrease from baseline on echocardiogram after anthracycline based chemotherapy.
  6. Patients must not have gastrointestinal tract disease or defect or previous history of colitis.
  7. Subjects must not be requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy.
  8. Patients must not have a known or suspected brain metastasis or active leptomeningeal disease.
  9. Must not have a 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.
  10. Must not have had a 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
Sponsors and Collaborators
M.D. Anderson Cancer Center
Astellas Pharma US, Inc.
Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02689427     History of Changes
Other Study ID Numbers: 2015-0488  NCI-2016-00367 
Study First Received: February 12, 2016
Last Updated: September 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Breast cancer
Invasive carcinoma of the breast
Triple-negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on October 21, 2016