Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

Inclusion Criteria(Screening):

* Female patients, age at diagnosis 18 - 75 years
* Histological confirmed unilateral primary invasive carcinoma of the breast
* Adequate surgical treatment with complete resection of the tumor (R0) and resection of \> or = 10 axillary nodes or SLN in clinically N0 patients
* T1 - T4 (if operable, inflammatory breast cancer is excluded)
* Her-2 non-over expressing tumor confirmed by IHC/FISH
* Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization
* Node positive disease or node negative disease with at least one other risk factor (tumor size \> or = 2 cm, grade \> or = 2, ER and PR negative, high uPA//PAI-1 levels)
* No evidence for distant metastasis (M0) after conventional staging
* Performance Status ECOG \< or = 1 or KI \> or = 80 %
* The patient must be accessible for treatment and follow-up
* Written informed consent for central pathology review and evaluation of Recurrence Score (HR positive) and participation in the planB trial prior to beginning specific protocol procedures

HR positive patients:

* Patient willingness to participate in adjuvant chemotherapy planB trial if RS \> 11
* Indication for chemotherapy given provided either \> 4 involved lymph nodes or RS \> 11 in 1-3 lymph nodes or N0 disease

Additional Inclusion Criteria (Randomisation to chemotherapy):

* Laboratory requirements (within 21 days prior to randomization):

  * Leucocytes \> or = 3.5 109/L
  * platelets \> or = 100 109/L
  * haemoglobin \> or = 10 g/dL
  * total bilirubin \< or = 1 ULN
  * ASAT (SGOT) and ALAT (SGPT) \< or = 2.5 UNL
  * creatinine \< 175 ymol/L (2 mg/dL)
* Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients
* LVEF within normal limits of each institution measured by echocardiography or MUGA scan and

Exclusion Criteria(Screening):

* HER2 over expression confirmed by IHC/FISH/CISH
* Known hypersensitivity reaction to the compounds or incorporated substances
* Known polyneuropathy \> or = grade 2
* Severe and relevant comorbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease.
* Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri or ipsilateral ductal carcinoma in-situ (DCISpTis of the breast)
* Non-operable breast cancer including inflammatory breast cancer
* Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
* Male breast cancer
* Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less then 1% failure rate) non-hormonal contraceptive measures during the study treatment
* Breast feeding woman
* Sequential breast cancer
* Lack of patient compliance

Additional Exclusion Criteria (Randomisation):

* Inadequate organ function including:

  * Leucocytes \< 3,5 G/l
  * platelets \< 100 G/l
  * creatinine or bilirubin above normal limits
  * alkaline phosphatise \> 5 UNL
  * ASAT and/or ALAT associated with AP \> 2.5 UNL
  * uncompensated cardiac function
* Time since axillary dissection \> 42 days