Statement: Prior use of Anthracycline drugs in the last 6 months for anticancer therapy is prohibted for patients in the primary trial, but not for patients in the secondary trial.
Primary_evidence: Inclusion Criteria:   Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.   Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).   Adequate organ function (bone marrow, hepatic, renal, cardiac). Exclusion Criteria:   Prior anthracyclines as part of prior anticancer therapy.   Concurrent antitumor therapy.   Second primary malignancy.   Serious concomitant systemic disorder.   Pre-existing sensorial or motor neuropathy Grade 1.
Secondary_evidence: Inclusion Criteria:   Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment   Postmenopausal status defined as cessation of menses for >1 year or FSH > 20 mIU/mL (within the past month)   Age  21 years   No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry   Signed informed consent Exclusion Criteria:   Treatment with other investigational drugs within 6 months of study entry   Other serious intercurrent medical illness