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Active Not Recruiting NCT02955394

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

Conditions: Breast Cancer

Sex: Female
Ages: 18 Years – 101 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 61
Sponsor: University of Colorado, Denver

Location: University of Colorado Aurora Colorado

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.

Eligibility 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02955394). StuddyBuddy aggregates publicly available trial information.