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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthony Elias; University of Colorado, Denver
• Collaborator: United States Department of Defense
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

• ER+ Her2- breast cancer

• Stage at least T2 or greater

• Planned to get local surgery

• Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent ovarian suppression.

• At least 18 years of age

• Not on anticoagulants

• PS 0-2

• Able to swallow study drug and comply with study requirements

• ANC >1000/uL, platelets >75,000/uL at screening visit

• Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless an alternate nonmalignant etiology exists (eg, Gilbert's disease)

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or < 5 times ULN if patient has documented liver metastases

• Creatinine < 1.5 times ULN

• INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy

• Willing to donate blood for research at 4 time points

• Willing to undergo core biopsies for research at study entry and at ~4 weeks.

• Willing to donate tissue to research from the surgical specimen

• Written informed consent obtained prior to biopsies and blood samples

Exclusion Criteria:

• Current or previously treated brain or leptomeningeal metastases

• History of seizures

• Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide, enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464).

• Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal estrogens are allowed if necessary for patient comfort.