Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer

Status: Recruiting
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT01889238 (View complete trial on
DFCI Protocol ID: 13-340


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.


Conducting Institutions:
Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
Nadine Tung, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Ian Krop, MD, Dana-Farber Cancer Institute

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

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 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.
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