[c09aa8]: / clusters / clusters342final / clust_289.txt

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For patients who have not started their chemotherapy prior to registration, the interval between definitive tumor-related surgery and 1st step registration must be between 21-70 days; for patients entering on the study who have already received up to 3 months of adjuvant chemotherapy as per the treating institution, the interval between definitive tumor-related surgery and day one of adjuvant chemotherapy must be between 21-77 days
Complete history and physical examination including weight and Zubrod status within 31 days of study entry (or within 31 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Complete blood count (CBC)/differential obtained within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Serum total bilirubin =< twice the institutional upper limit of normal (ULN) within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Creatinine levels =< twice the institutional upper limit of normal within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Serum glutamic oxaloacetic transaminase (SGOT) must be =< 2.5 x institutional ULN within 21 days of registration on study (or within 21 days prior to day 1 of chemotherapy post-surgery for those patients having started chemotherapy prior to first step registration)
Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue throughout the duration of study
Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
Complete blood count (CBC)/differential obtained within 28 days prior to step 2 registration
Chemotherapy =< 21 days prior to first administration of study treatment and/or monoclonal antibody =< 6 weeks prior to first administration of study treatment
Blood cell count (CBC)/differential obtained within 60 days prior to registration on study
No investigational agent within 21 days prior to registration
Patients may receive bisphosphonates or denosumab concurrently with study treatment; if started prior to registration, it must be started at least 7 days prior to registration
Patients must have serum chemistries (including potassium and magnesium) within 21 days prior to registration to obtain baseline values
Patients must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration; (CIS disease is not expected to have been completely excised)