Status:
COMPLETED
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Conditions:
Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 estro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01889238
Start Date
June 12 2013
End Date
January 10 2024
Last Update
December 13 2024
Active Locations (132)
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1
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States, 80907
2
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States, 80228
3
Rocky Mountain Cancer Center Sky Ridge
Lone Tree, Colorado, United States, 80124
4
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States, 80124