Statement: Patients with Cervical carcinoma in situ are excluded from the primary trial.
Primary_evidence: Inclusion Criteria:   female patients, 18-70years of age;   histologically-proven invasive breast cancer;   no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;   no distant disease/secondary cancer. Exclusion Criteria:   pregnant or lactating women;   pre-operative local treatment for breast cancer;   prior or concurrent systemic antitumor therapy;   clinically significant cardiac disease.