Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors

Inclusion Criteria

• •1. Modified radical mastectomy (or breast conserving surgery) and axillary clearance, histologically confirmed stage IIA, IIB or IIIA adenocarcinoma (excluding supraclavicular lymph nodes) of the breast, with 4 or more involved axillary lymph nodes. Presence of tumor cells near or in the resection margins at microscopic examination is acceptable
• •2. The primary tumor must be immunohistochemically negative for HER-2/neu expression. An immunohistochemistry score of 1+ is also acceptable. A score of 3+ is not acceptable. A score of 2+ is only acceptable if a FISH analysis (or equivalent) has clearly shown that there is no HER-2/neu gene-amplification
• •3. No prior chemotherapy or radiotherapy
• •4. No evidence of distant metastases
• •5. Age \< 50 years
• •6. Performance status (ECOG-ZUBROD) 0 or 1;
• •7. Normal bone marrow function, WBC \> 4.0 x 109/l, platelets \> 100 x 109/l;
• •8. Adequate renal function (creatinine clearance \> 60 ml/min.);
• •9. Adequate hepatic function (serum bilirubin \< 25 umol/l);
• •10. Study treatment must begin within 6 weeks of surgery;
• •11. No other malignancy except adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin;
• •12. No significant prior or concomitant disorder that might interfere with adherence to the intensive treatment regimen, including but not limited to a history of angina, myocardial infarction or heart failure, severe lung function impairment, peptic ulcer disease, etc.;
• •13. Availability for follow-up.