- The patient must have signed and dated an institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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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, pathological tumor must be greater than or equal to 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+
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IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells
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ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells
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