TAC Versus TC for Adjuvant Breast Cancer

Inclusion Criteria

• •A woman will be eligible for inclusion in this study if she meets all of the following criteria:
• •Age \>18 to \<70 years old.
• •Has known ER and PR status
• •Has HER2 nonamplified disease, confirmed by FISH
• •Has known menopausal status (see Section 7.3 for criteria)
• •Meets 1 of the 3 following criteria:
• •* T1-3N1-3M0 if ER positive or negative
• •* T2-3N0M0 if ER positive or negative
• •* T1N0M0 if ER and PR negative
• •Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS)
• •Has had no prior chemotherapy unless \>5 years ago
• •Has an ECOG Performance Status (PS) 0-1
• •Has laboratory values of: See protocol for specific details
• •Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
• •Has normal cardiac function as evidenced by a LVEF \>50%, but WNL by institutional standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same modality must be used consistently throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be WNL by institutional standard.
• •Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease
• •Has had baseline bilateral mammography
• •It has been \<84 days since the date of definitive surgery (eg, mastectomy or, in the case of a breast-sparing procedure, axillary dissection) with adequate wound healing, as determined by the Treating Physician
• •Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential \[not surgically sterilized and between menarche and 1 year postmenopause\])
• •If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive only) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
• •Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VI).
• •Has signed a Patient Informed Consent Form
• •Has signed a Patient Authorization Form