drugset / Trial / NCT01889238
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
Phase 2
Completed
118 enrolled
Pfizer
Astellas Pharma Inc · collabMedivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab
NaSingle-groupOpen-labelTreatment
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 estrogen or progesterone receptor and are not Her2 amplified.
Timeline
- Start
- 2013-06-12
- Primary completion
- 2015-03-01
- Completion
- 2024-01-10
Publications
- Kumar V, Yu J, Phan V, Tudor IC, Peterson A, Uppal H. Androgen Receptor Immunohistochemistry as a Companion Diagnostic Approach to Predict Clinical Response to Enzalutamide in Triple-Negative Breast Cancer. JCO Precis Oncol. 2017 Nov;1:1-19. doi: 10.1200/PO.17.00075.
- Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |