Study Approval and Patient Eligibility
Breast Cancer
ONCOLOGY, BREAST CANCER
This protocol was approved by the Mayo Clinic institutional review board and each site institutional review board within the participating Translational Breast Cancer Research Consortium (TBCRC) institutions (During the preregistration period, a biopsy specimen of a metastatic site was obtained for central ERα testing (for stratification). Key registration criteria included adequate blood cell counts and chemistry results, an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1, no systemic therapy 21 days or fewer before registration, no need for treatment with a chronic proton pump inhibitor or H2 antagonist, and no visceral crisis.