Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments enzalutamide, exemestane, placebo (for enzalutamide)
Phase phase 2
Target androgen receptor
Sponsor Medivation, Inc.
Collaborator Astellas Pharma Inc
Start date December 2013
End date April 2017
Trial size 247 participants
Trial identifier NCT02007512, MDV3100-12

Summary

The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Enzalutamide 160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food and exemestane 50mg capsule once daily after food.
enzalutamide MDV3100
160 mg/day administered as four 40-mg soft gelatin capsules by mouth once daily with or without food.
exemestane
50 mg capsule administered as a single capsule by mouth once daily after food.
(Active Comparator)
placebo and exemestane 25 mg once daily after food.
exemestane
25 mg capsule administered as a single capsule by mouth once daily after food.
placebo (for enzalutamide)
Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: 24 Months

Secondary Outcomes

Measure
Clinical Benefit Rate
time frame: 24 Months
Pharmacokinetics
time frame: 24 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Willing and able to provide informed consent; - Postmenopausal; - Advanced histologically confirmed breast cancer that is ER+, PgR+, or both, and HER-2 normal; - Up to one prior hormone therapy and up to one prior chemotherapy in the advanced setting is allowed; - Availability of a representative, formalin-fixed, paraffin-embedded tumor specimen that enabled the diagnosis of breast cancer with viable tumor cells in a tissue block or unstained serial slides accompanied bay an associated pathology report; - Measurable disease. Patients with non-measurable bone or skin disease as their only manifestation of advanced breast cancer are also eligible; - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1; Exclusion Criteria: - Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator; - Any condition or reason that interferes with the patient's ability to participate in the trial, that may cause undue risk, or complicates the interpretation of safety data, in the opinion of the investigator; - Current or previously treated brain metastasis or leptomeningeal disease; - 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); - Requires treatment for tuberculosis or HIV infection; - Radiation therapy within 7 days before randomization; - History of another invasive cancer within 5 years before randomization; - History of seizure or any condition that may predispose to seizure; - Clinically significant cardiovascular disease; - Active gastrointestinal disorder; - Major surgery within 28 days prior to randomization; - Treatment with any oral anticancer or with any non-hormonal anticancer agent within 14 days before randomization; - Treatment with any approved or investigational agent that blocks androgen synthesis or targets the androgen receptor; - Treatments with any of the following medications within 14 days before randomization: Estrogens, Androgens, or Systemic radionuclides; - Hypersensitivity reaction to exemestane.

Additional Information

Official title A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal
Description This is a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2-Normal.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Medivation, Inc..