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

NCT01889238

CompletedPhase 2

Sponsor: Pfizer

Conditions: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer

Interventions: Enzalutamide

Countries: United States, Belgium, Canada, Ireland, Italy, Spain, United Kingdom

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.

Locations (132)

Colorado Springs, Colorado, United States
Lakewood, Colorado, United States
Lone Tree, Colorado, United States
Lone Tree, Colorado, United States
Altamonte Springs, Florida, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
Brandon, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hudson, Florida, United States
Largo, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
Sarasota, Florida, United States
Spring Hill, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
Venice, Florida, United States
Venice, Florida, United States
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