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

Phase 1

• Conditions: Breast Cancer; MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000698-57-GB
• Lead Sponsor: Medivation, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-16
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 118

Inclusion Criteria

• 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

Exclusion Criteria

• 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