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A phase 2, randomized, double-blind, placebo-controlled, multicenter study of efficacy and safety of enzalutamide in combination with exemestane in patients with advanced breast cancer that is estrogen or progesterone receptor-positive and HER2-normal

ClinicalTrials.gov · COMPLETED, 2024

247 participants

Abstract

The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.

Conditions: Breast Cancer.

Primary outcome: Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS); Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS).

Enrollment: 247 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 247 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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