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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Advanced, Androgen Receptor Positive Triple Negative Breast Cancer

Treatments

Drug: Enzalutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01889238

2013-000698-57 (EudraCT Number)

C3431007 (Other Identifier)

MDV3100-11

Details and patient eligibility

About

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.

Enrollment

118 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.