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ACTIVE NOT RECRUITING
NCT02955394
PHASE2

Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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.

Official title: Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 101 Years

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2017-09-21

Completion Date

2027-02

Last Updated

2025-07-09

Healthy Volunteers

No

Conditions

Interventions

DRUG

Enzalutamide

160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.

DRUG

Fulvestrant

500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)

Locations (3)

University of Colorado

Aurora, Colorado, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

West Cancer Center

Germantown, Tennessee, United States