Breast Cancer Clinical Trial
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
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.
Full Description
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. After consent, all patients will get a tissue biopsy, and than half the patients will get fulvestrant alone (standard dosing) and the other half of the patients will get fulvestrant plus enzalutamide. At ~4 weeks, a biopsy will be done and therapy will be continued. Hormone therapy will continue for ~4 months at which point the patients will undergo surgical resection.
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.
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There are 3 Locations for this study
Aurora Colorado, 80045, United States
New York New York, 10065, United States
Germantown Tennessee, 38138, United States
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