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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
University of Colorado
Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
West Cancer Center
Germantown, Tennessee, United States
Number of Patients With a PEPI Score Equal to Zero at Post Treatment
The preoperative endocrine prognostic index (PEPI) is a validated measure of pathologic response to endocrine therapy. It is a model that combines estrogen receptor (ER) level, pathologic tumor site, nodal status, and Ki67 score at the time of surgery to predict subsequent risk of cancer recurrence. PEPI scoring is typically discretized into three risk groups: 0 (low risk of recurrence and best outcome), 1-3 (intermediate risk), and \>= 4 (high risk). This study was concerned only with the distinction between zero and non-zero PEPI scores. Zero is the minimum score, and there is no maximum score. Lower scores are better.
Time frame: 16 Weeks
Disease-free Survival
Disease-free survival is defined as the time in months from the start of fulvestrant until documented disease progression or death. Complete and partial response for the single drug arm and combination of enzalutamide/fulvestrant arm separately.
Time frame: 15 months
Correlation Between PEPI Score and Disease-free Survival, Clinical Benefit Rate, and Overall Response Rate
To assess the association between PEPI score and the clinical, outcomes such as DFS, ORR, clinical benefit for all subjects.
Time frame: 4 years
Androgen Receptor (AR) Expression
The strength of AR signaling was measured by the percentage of downstream AR-regulated genes that were expressed.
Time frame: 16 Weeks
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