- Documentation of Disease: Subjects must have histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer.
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A core biopsy interpreted as invasive cancer meets this criterion
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- if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy).
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Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery, eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery
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- if patient is eligible based on either, they are eligible for the study.
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Bilateral breast carcinoma is allowed provided diagnoses are synchronous - that is, within 3 months of one another - and at least one of the two breast carcinomas meet the eligibility criteria and neither Her-2 positive or inflammatory.
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No evidence of metastatic disease
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Her-2 negative, defined as:
In-situ hybridization (ISH) ratio of < 2.0 (if performed).
Immunochemistry (IHC) staining of 0-2+ (if performed).
Deemed to not be a candidate for Her-2 directed therapy.
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