Inclusion Criteria:

- Histological proven primary breast cancer

- Tumour size >0.5 cm and <5 cm (pT1b-pT2, pN0, M0)

- Axillary lymph nodes tumour free (node-negative disease)

- Adequate surgical procedure: R0-resection and axillary dissection with more than 10
lymph nodes examined or adequate sentinel procedure in a qualified centre

- Frozen tumour tissue available (for analysis of biological markers and microarrays,
centres with biological risk assessment only). The material has to be stored in
liquid nitrogen immediately after excision.

- Paraffin blocks or (at least) pathology slides of primary tumour (stained and
unstained) and axillary nodes (stained) available for central review.

- HER-2/neu determination by immunohistochemistry. Patients will be stratified to be
HER-2/neu-negative or HER-2/neu-positive (HER-2/neu Score 3+, or HER-2/neu Score 2+
and FISH positive).

- No distant metastasis

- Age >18 years, <70 years

- Performance status ECOG <2 (WHO Performance Status 0-1)

- Adequate cardiac function (echocardiographically measured left ventricular ejection
fraction (LVEF) or shortening fraction (SF) within the normal limits, i.e. ≥55%)

- Adequate bone function (neutrophil count >1.5 x109 /l and platelet count >100 x109
/l)

- Adequate renal function (serum creatinine <120 µmol/l or 1.35 mg/dl) and hepatic
function (serum bilirubin <1 x UNL, ASAT or ALAT (SGOT or SGPT) <2,5 x UNL)

- Before patient registration/randomization, written informed consent must be obtained
according to ICH/EU GCP, and national/local regulations

Exclusion Criteria:

- Chemotherapy contraindicated

- Inflammatory breast cancer, tumour infiltrated axillary lymph nodes including the
sentinel node.

- Other concomitant pathology compromising survival (at entry), or preventing the
administration of chemotherapy with either FEC or Docetaxel

- Other serious illness or medical condition that may interfere with the understanding
and giving of informed consent and the conduct of the study

- Estimated life-expectancy <10 years (irrespective of breast cancer diagnosis)

- Patient not accessible for treatment and follow up

- Endocrine treatment not according to the latest standard recommendations of the AGO
Kommission "Mamma"

- Pregnancy, lactation (sufficient non-hormonal contraception in fertile women
required)

- Surgery more than six weeks ago at the start of chemotherapy

- Pre-existing polyneuropathy

- Previous or concomitant other malignancy (including contralateral breast cancer)
except adequately treated basal or squamous cell carcinoma of the skin or in situ
carcinoma of the cervix

- Prior chemotherapy or radiotherapy or endocrine therapy