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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02689427
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : March 25, 2019
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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
120 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

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 with at least 1.0 cm of residual disease as measured by 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. Androgen Receptor will be quantified using a CLIA-compliant assay for AR on a biopsy specimen obtained prior to the start of treatment. AR- positivity is defined as >/= 10% 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 0 - 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 who have received previous antitumor therapies (other than anthracycline-based neoadjuvant chemotherapy for the current cancer event).
  2. Breast-feeding at screening or planning to become pregnant during the course of therapy.
  3. Patients who have had major surgery within 21 days before Cycle 1, Day 1.
  4. Patients with a known history of hypersensitivity to paclitaxel that did not resolve with pre- medication.
  5. Patients with left ventricular ejection fraction <50% or 10% decrease from baseline on echocardiogram after anthracycline based chemotherapy.
  6. Patients with gastrointestinal impairment that would affect the absorption of Enzalutamide or previous history of colitis.
  7. Subjects requiring daily corticosteroids, other than those given as premedication for the anthracycline-based chemotherapy.
  8. Patients with known or suspected brain metastasis or active leptomeningeal disease.
  9. 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. 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02689427

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Contact: Naoto Ueno, MD, PHD 713-792-2817

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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.
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Principal Investigator: Naoto Ueno, MD, PHD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02689427     History of Changes
Other Study ID Numbers: 2015-0488
NCI-2016-00367 ( Registry Identifier: NCI CTRP )
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
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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