A Multinational Study to Evaluate the Safety and Activity of Enzalutamide in Women Whose Breast Cancer Expresses the Androgen Receptor but Does Not Express Estrogen or Progesterone Receptors, and is Not Amplified for the Epidermal Growth Factor Receptor, HER2
- Conditions
- Breast CancerMedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000698-57-IE
- Lead Sponsor
- Medivation, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 95
• Advanced AR+ (any nuclear AR staining by IHC) TNBC, where advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent;
• Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer;
• Either measurable disease or bone-only nonmeasurable disease;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Current or previously treated brain metastasis or active leptomeningeal disease; head imaging is required during screening;
• Current hormone replacement therapy;
• Abnormal hematology, liver function tests and creatinine laboratory values at screening;
• History of seizure or any condition that may predispose to seizure;
• History of loss of consciousness or transient ischemic attack within past 12 months;
• An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease; uncontrolled celiac disease);
• Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (e.g., abiraterone acetate, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700); patients who received treatment for < 28 days or placebo on an investigational study are acceptable;
• Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine clinical benefit rate in patients with AR+ triple-negative breast cancer (TNBC).;Secondary Objective: To determine additional measures of clinical benefit including response rate, duration of response and PFS<br>To assess the safety, tolerability and PK of enzalutamide and its active metabolite<br>;Primary end point(s): Clinical benefit rate, defined as the proportion of evaluable patients with a best response of CR, PR, or SD > 16 weeks;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Additional measures include clinical benefit at >24 weeks, best objective response rate, duration of response and PFS, will be evaluated;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression