Inclusion Criteria

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.