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NCT number NCT02955394
Study type Interventional
Source University of Colorado, Denver
Contact Tiffany Colvin
Phone 720-848-0664
Email TIFFANY.COLVIN@UCDENVER.EDU
Status Recruiting
Phase Phase 2
Start date September 21, 2017
Completion date November 2018

Clinical Trial Summary

This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.


Clinical Trial Description

This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment. After consent, all patients will get a tissue biopsy, and than half the patients will get fulvestrant alone (standard dosing) and the other half of the patients will get fulvestrant plus enzalutamide. At ~4 weeks, a biopsy will be done and therapy will be continued. Hormone therapy will continue for ~4 months at which point the patients will undergo surgical resection.


Study Design


Related Conditions & MeSH terms


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