ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24 weeks from surgery
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100,000 mm^3
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =< 2.5 x ULN
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =< 2.5 x ULN
REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA:
ELIGIBILITY CRITERIA FOR STEP 0
ELIGIBILITY CRITERIA FOR STEP 1
Site must verify that there is no known change in the step 1 eligibility since initial registration
INDUCTION ELIGIBILITY CRITERIA-STEP 1
POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)
Patients should meet the eligibility criteria for RANDOMIZATION TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
Patients must have met eligibility criteria for the screening step
ELIGIBILITY CRITERIA FOR PREREGISTRATION (STEP 0):
ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1):
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Patients randomized to Arm 1 may opt to switch to the 3-drug regimen following disease progression; these patients must be re-registered to the study and meet the eligibility criteria below
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): ECOG performance status 0-2
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Platelet count >= 50 x 10^9/L
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): AST and ALT < 2.5 x upper limits of normal (ULN)
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): Note: G-CSF and platelet transfusions cannot be used to increase counts to meet eligibility criteria
RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2): =< grade 2 peripheral neuropathy
PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)
ELIGIBILITY CRITERIA (STEP 1)
REGISTRATION ELIGIBILITY CRITERIA (STEP 1)
RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)
REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY
CONDITIONS FOR PATIENT ELIGIBILITY PRIOR TO STEP 2 REGISTRATION (HER2-POSITIVE PATIENTS ONLY)
REGISTRATION (POST-SURGERY) ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY CRITERIA
REGISTRATION ELIGIBILITY
PRE-REGISTRATION (STEP 0) ELIGIBILITY CRITERIA:
REGISTRATION (STEP 1) ELIGIBILITY CRITERIA:
ELIGIBILITY CRITERIA FOR CROSSOVER REGISTRATION
STEP 1 ELIGIBILITY CRITERIA
STEP 2 ELIGIBILITY CRITERIA
REGISTRATION/RANDOMIZATION ELIGIBILITY CRITERIA
Site must verify that there is no known change in the step 1 eligibility since initial registration
PATIENT REGISTRATION ELIGIBILITY CRITERIA:
STEP 3: ELIGIBILITY CRITERIA PRIOR TO TREATMENT OR OBSERVATION
REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA:
PRE-REGISTRATION EXCLUSION CRITERIA
EXCLUSION CRITERIA FOR PRE-REGISTRATION:
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION ELIGIBILITY
PRE-REGISTION ELIGIBILITY
ELIGIBILITY CRITERIA FOR PRE-REGISTRATION
EXCLUSION CRITERIA FOR PRE-REGISTRATION
PRE-REGISTRATION (PRE-SURGERY) ELIGIBILITY CRITERIA
Pre-registration eligibility criteria continue to be met
PRE-REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA: Prior chemotherapy for this cancer (excluding initiation of best practice chemotherapy to be given as standard of care, which may be initiated after the pre-registration bone marrow collection but before final confirmation of eligibility and randomization)
PRE-REGISTRATION EXCLUSION CRITERIA: Previous treatment with trastuzumab or any other Her2 targeted therapy
REGISTRATION EXCLUSION CRITERIA: Prior chemotherapy for this cancer (excluding initiation of best practice chemotherapy to be given as standard of care, which may be initiated after the pre-registration bone marrow collection but before final confirmation of eligibility and randomization)
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA:
Pre-procedure Exclusion Criteria
PATIENT PRE-REGISTRATION ELIGIBILITY CRITERIA:
PRE-REGISTRATION EXCLUSION
PRE-REGISTRATION EXCLUSION:
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION EXCLUSION CRITERIA
PRE-REGISTRATION ELIGIBILITY CRITERIA