This trial is active, not recruiting.

Condition advanced, androgen receptor positive triple negative breast cancer
Treatment enzalutamide
Phase phase 2
Target androgen receptor
Sponsor Medivation, Inc.
Collaborator Astellas Pharma Inc
Start date June 2013
End date March 2015
Trial size 118 participants
Trial identifier NCT01889238, 2013 000698 57, MDV3100-11


The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
160 mg administered as four 40 mg soft gelatin capsules orally once daily
enzalutamide Xtandi®
160 mg administered as four soft gelatin capsules orally once daily

Primary Outcomes

Clinical Benefit Rate
time frame: ≥ 16 weeks

Secondary Outcomes

Clinical Benefit Rate
time frame: ≥ 24 weeks
Best Objective Response Rate
time frame: ≥ 16 weeks
Duration of Response
time frame: ≥ 16 weeks
Time to Response
time frame: ≥ 16 weeks
Progression Free Survival (PFS)
time frame: ≥ 16 weeks
Pharmacokinetics - Ctrough (predose plasma concentration)
time frame: ≥ 16 weeks

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Women at least 18 years of age; - Advanced AR+ TNBC; - Availability of a representative tumor specimen: - Either measurable disease or bone only nonmeasurable disease; - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: - Any severe concurrent disease, infection, or comorbid condition; - 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; - Current or previously treated brain metastasis or active leptomeningeal disease; - Current hormone replacement therapy; - Local palliative radiation therapy within 7 days before day 1; - History of another invasive cancer within 5 years of day 1; - Absolute neutrophil count < 1500/µL, platelet count < 75,000/µL, or hemoglobin < 9 g/dL (5.6 mmol/L) at the screening visit; - Creatinine > 1.5 times upper limit of normal (ULN) at the screening visit; - History of seizure or any condition that may predispose to seizure; - Clinically significant cardiovascular disease; - Active gastrointestinal disorder affecting absorption; - Major surgery within 4 weeks before day 1; - Treatment with any commercially available anticancer agent within 14 days before day 1; - Treatment with any investigational agent within 2 weeks before day 1; - Treatment with any of the following medications within 2 weeks before day 1: Estrogens, including hormone replacement therapy; Androgens (testosterone, dihydroepiandrosterone, etc);Systemic radionuclides (eg, samarium or strontium);Vaccine therapy; - Hypoglycemic episode requiring medical intervention while on insulin treatment within 12 months before day 1; - Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.

Additional Information

Official title A Phase 2, Single Arm, Open Label, Multicenter Study of the Clinical Activity and Safety of Enzalutamide in Patients With Advanced, Androgen Receptor Positive, Triple Negative Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Medivation, Inc..