CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- The patient must have signed and dated an institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
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All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:
- By pathologic evaluation, primary tumor must be pT1-3
- By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
- If pN0, tumor must be > 3.0 cm
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The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows:
- Immunohistochemistry (IHC) 0-1+; or
- IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells; or
- ISH non-amplified with a ratio of HER2 to CEP17 < 2.0, and if reported, average HER2 gene copy number < 4 signals/cells
- The tumor must have been determined to be estrogen receptor (ER)-and progesterone receptor (PgR)-negative assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients with < 1% ER and PgR staining by IHC are considered negative
- The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
- For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
- For patients who undergo mastectomy, the margins must be free of residual gross tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)
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The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.
- The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days
- Absolute neutrophil count (ANC) must be >= 1200/mm^3
- Platelet count must be >= 100,000/mm^3
- Hemoglobin must be >= 10 g/dL
- Total bilirubin must be =< upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin
- Alkaline phosphatase must be =< 2.5 x ULN for the lab
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Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab
- Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN
- Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (computed tomography [CT], magnetic resonance imaging [MRI], positron emission tomography [PET]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements above are met
- Patients with alkaline phosphatase that is > ULN but =< 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease
- Adequate renal function determined within 6 weeks prior to randomization defined as the most recent serum creatinine =< ULN or measured or calculated creatinine clearance > 60 mL/min
- Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days prior to randomization; (LVEF assessment performed by 2-dimensional [D] echocardiogram is preferred; however, multi gated acquisition [MUGA] scan may be substituted based on institutional preferences;) the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal
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CRITÈRES D'EXCLUSION |
(EN)
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