Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Sponsor: University of Colorado, Denver
ClinicalTrials ID:NCT02955394
This phase II trial evaluates fulvestrant with or without enzalutamide in postmenopausal women with locally advanced AR+/ER+/Her2- breast cancer. Participants undergo biopsies and receive treatment for ~4 months before surgery. Eligibility includes ER+ Her2- status, stage T2+, and specific health criteria. Interventions involve daily enzalutamide and standard fulvestrant dosing.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado | 80045 | Aurora | Colorado |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| West Cancer Center | 38138 | Germantown | Tennessee |
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