← Back to all trials
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.
Source: ClinicalTrials.gov (NCT02955394). StuddyBuddy aggregates publicly available trial information.