A Multinational Study to Evaluate the Safety and Activity of Enzalutamide in Combination With Exemestane in Women With Hormone-Positive Breast Cancer That Is Normal for HER-2

Phase 1

• Conditions: Breast Cancer; MedDRA 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: EUCTR2013-002717-35-IE
• Lead Sponsor: Medivation, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-12
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Advanced, histologically confirmed breast cancer (primary tumor) that is ER+ and/or PgR+, and HER2-normal
• Cohort 1: patients who have not previously received hormone treatment for advanced breast cancer and the subset that is also AR+
• Cohort 2: patients who previously progressed following 1 hormone treatment for advanced breast cancer and the subset that is also AR+
• Up to one prior chemotherapy regimen for advanced disease is allowed for either Cohort
• Non-measurable bone and skin disease is allowed
• Patients must be post-menopausal
• Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer;
• 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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

• Current or previously treated brain metasis or active leptomeningeal disease;
• Abnormal hematology, liver function tests or 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 12 months before randomization;
• An active gastrointestinal disorder affecting absorption (eg, gastrectomy, uncontrolled celiac disease);
• Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (eg, 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.);
• Prior therapy (> 28 days) with exemestane in the metastatic setting. (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible.);
• 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