A phase 2, single-ARM, open-label, multicenter study of the clinical activity and safety of enzalutamide in patients with advanced, androgen receptor-positive, triple-negative breast cancer
Abstract
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.
Conditions: Advanced, Androgen Receptor Positive Triple Negative Breast Cancer.
Primary outcome: Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population; Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population.
Enrollment: 118 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 118 participants or records.
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