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

NCT02955394 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-07-09

Study results available
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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.

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)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Anthony D Elias, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
101 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2023-02-17
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02955394 on ClinicalTrials.gov