Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer

Exclusion Criteria

• •The primary tumor must be T1-3 by clinical and pathologic evaluation.
• •Lymph nodes obtained from all axillary staging procedures must be pN0 according to pathologic staging criteria of the 6th edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual.
• •Patients must have undergone axillary nodal staging procedures, for example sentinel node (SN) biopsy alone, SN biopsy followed by axillary sampling or completion dissection, or axillary node dissection to obtain lymph nodes for pathologic evaluation. If the patient has palpable nodes, axillary dissection is required.
• •Patients must have an estrogen receptor (ER) analysis performed on the primary tumor prior to randomization. If ER is negative, then progesterone receptor (PgR) analysis must be performed. If ER is positive, PgR analysis is desired, but not mandatory. ("Marginal" or "borderline" results \[i.e., those not definitively negative\] will be considered positive regardless of the methodology used.)
• •Patients must have had either a lumpectomy or total mastectomy.
• •Patients must have no clinical or radiologic evidence of metastatic disease.
• •Patients with skeletal pain are eligible for inclusion in the study if bone scan or roentgenological examination fail to disclose metastatic disease. Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy.
• •The patient's menopausal status must be determined prior to randomization.
• •* Pre- and postmenopausal women are eligible. The following criteria will be used to define postmenopausal:
• •* a prior documented bilateral oophorectomy, or
• •* a history of at least 12 months without spontaneous menstrual bleeding, or
• •* age 55 or older with a prior hysterectomy or
• •* age 54 or younger with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the lab's postmenopausal range.
• •* Women failing to meet one of these criteria will be classified as premenopausal.
• •At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray or chest CT within the past 3 months; bilateral mammogram within the past 6 months; and pelvic exam (for women who have a uterus and who will be receiving tamoxifen) within the past year.
• •Within 3 months prior to entry, the patient must have a baseline LVEF measured by Multi Gated Acquisition (MUGA) scan or echocardiogram equal to or greater than the lower limit of normal for the facility performing the procedure.
• •At the time of randomization:
• •* The postoperative absolute granulocyte count (AGC) must be greater than or equal to 1500/mm3 (or greater than or equal to 1200/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variant of normal).
• •* Postoperative platelet count must be greater than or equal to 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the ULN for the lab.
• •* There must be postoperative evidence of adequate hepatic function, i.e.,
• •* total bilirubin must be less than or equal to ULN for the lab unless the patient has a chronic Grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome due to slow conjugation of bilirubin; and
• •* alkaline phosphatase must be less than 2.5 x ULN for the lab; and
• •* the aspartate transaminase (AST) \[serum glutamic-oxaloacetic transaminase (SGOT)\] must be less than or equal to 1.5 x ULN for the lab.
• •* There must be postoperative evidence of normal renal function (serum creatinine less than or equal to ULN).
• •Pure tubular or mucinous adenocarcinomas.
• •Bilateral malignancy (including DCIS) or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
• •Primary tumor staged as T4 for any reason.
• •Suspicious palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes. Patients with these conditions are considered ineligible unless there is biopsy evidence that these are not involved with tumor.
• •Prior history of breast cancer, including DCIS (patients with a history of lobular carcinoma in situ \[LCIS\] are eligible).
• •Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exceptions are:
• •* Hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before study entry. In such a case, hormonal therapy must stop at or before randomization and be re-started, if indicated, following chemotherapy.
• •* If patient is enrolled in NSABP B-39 and randomized to Group 2, partial breast irradiation (PBI) may be completed prior to beginning treatment on NSABP B-36.
• •Prior anthracycline therapy for any malignancy.