drugset / Trial / NCT02929576

Efficacy and Safety Study of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer

NCT02929576 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate and compare the clinical benefit and safety of treatment with enzalutamide in combination with paclitaxel chemotherapy or as monotherapy versus placebo with paclitaxel in patients with locally advanced or metastatic, diagnostic-positive, triple-negative breast cancer (TNBC).

Timeline

Start
2016-09
Primary completion
2019-04
Completion
—

Outcome

Outcome not reported

Stopped: “Further understanding about the role of androgen signaling in TNBC was required”

Drugs

EvaluationDrugModalityDoseRoute
Subject Enzalutamide Other / unclassified 160 mg —
Background Paclitaxel Small molecule 90 mg/m2 Intravenous

Indications