Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
Completed · Phase 2
Conditions studied: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT01889238
- Run by
- Pfizer
- People needed
- 118
- Starts
- 2013-06-12
- Expected to finish
- 2024-01-10
- Last updated by the study team
- 2024-12-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Rocky Mountain Cancer Centers — Lakewood, Colorado, United States
- Rocky Mountain Cancer Center Sky Ridge — Lone Tree, Colorado, United States
- Rocky Mountain Cancer Centers — Lone Tree, Colorado, United States
- Florida Cancer Specialists — Altamonte Springs, Florida, United States
- Florida Cancer Specialists — Bonita Springs, Florida, United States
- Florida Cancer Specialists — Bradenton, Florida, United States
- Florida Cancer Specialists — Brandon, Florida, United States
- Florida Cancer Specialists — Cape Coral, Florida, United States
- Florida Cancer Specialists — Clearwater, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialist South Division — Fort Myers, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialists — Fort Myers, Florida, United States
- Florida Cancer Specialists — Gainesville, Florida, United States
- Florida Cancer Specialists — Hudson, Florida, United States
- Florida Cancer Specialists — Largo, Florida, United States
- Florida Cancer Specialists — Naples, Florida, United States
- Florida Cancer Specialists — New Port Richey, Florida, United States
- Florida Cancer Specialists — Orange City, Florida, United States
- Florida Cancer Specialists — Orlando, Florida, United States
- Florida Cancer Specialists — Port Charlotte, Florida, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- Florida Cancer Specialists — Sarasota, Florida, United States
- Florida Cancer Specialists — Spring Hill, Florida, United States
- Rocky Mountain Cancer Centers — Colorado Springs, Colorado, United States
Full record on ClinicalTrials.gov
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