Inclusion Criteria:

1. Written informed consent for all study procedures according to local regulatory
requirements prior to beginning specific protocol procedures

2. Histologically confirmed unilateral or bilateral primary carcinoma of the breast

3. Age at diagnosis at least 18 years, female, and biologically not older than 65 years

4. Adequate surgical treatment with histological complete resection (R0) of the invasive
breast tumor. Choice of axilla surgery (clearance or sentinel node biopsy) is up to
the participating site.

5. Centrally confirmed ER/PR/HER2 and Ki-67 status detected on surgical biopsy. ER/PR
positive is defined as ≥1% stained cells and HER2-positive is defined as IHC 3+ in
>10% immunoreactive cells or FISH (or equivalent test) ratio ≥2.0. Formalin-fixed,
paraffin-embedded (FFPE) breast tissue has therefore to be sent to the Dept. of
Pathology at the Charité, Berlin prior to randomization

6. High risk breast cancer as defined as:

- HER2-positive or triple-negative tumors irrespective of nodal status

- luminal B-like tumors (ER and/or PgR positive, HER2 negative, Ki-67 >20%) with
involved lymph nodes

- 4 or more involved lymph nodes

7. Complete staging work-up within 3 months prior to randomization. All patients must
have bilateral mammography, breast ultrasound, breast MRI (optional), chest X-ray (PA
and lateral), abdominal ultrasound or CT scan or MRI and bone scan done. In case of
positive bone scan, bone X-ray (or CT or MRI) is mandatory. Other tests may be
performed as clinically indicated

8. Karnofsky Performance status index at least 80%

9. Estimated life expectancy of at least 10 years irrespective of the diagnosis of
breast cancer

10. Confirmed normal cardiac function by ECG and cardiac ultrasound (LVEF or shortening
fraction) within 2 weeks prior to randomization for patients with HER2-positive
disease. LVEF must be above 55%

11. Laboratory requirements:

Haematology

- Absolute neutrophil count (ANC) at least 2.0 x 109/L and

- Platelets at least 100 x 109/L and

- Hemoglobin at least 10 g/dL (6.2 mmol/L) Hepatic function

- Total bilirubin ≤ 1.5x times above upper normal limits (UNL) and

- ASAT (SGOT) and ALAT (SGPT) more tham 1.5x UNL and

- Alkaline phosphatase more than 2.5x UNL. Renal function

- Creatinine ≤ 1.25 UNL,

- Creatinine Clearance > 30ml/min (if Creatinine is above UNL, according to
Cockcroft-Gault)

12. Negative pregnancy test (urine or serum) within 14 days prior to randomization for
all women of childbearing potential

13. Complete baseline documentation must be submitted via MedCODES® and approved by GBG
Forschungs GmbH

14. Patients must be available and compliant for central diagnostics, treatment and
follow-up.

Exclusion Criteria:

1. Patients with luminal A-like tumors (ER and or PgR positive, HER2 negative and Ki-67
≤ 20%)and less than 4 involved lymph nodes

2. Non-operable breast cancer

3. Time since axillary dissection or SLNB >3 months (optimal < 1 month)

4. Previous and already (neoadjuvant or adjuvant) treated invasive breast carcinoma

5. Previous malignant disease being disease-free for less than 5 years (except CIS of
the cervix and non-melanomatous skin cancer).

6. Known or suspected congestive heart failure (>NYHA I) and / or coronary heart
disease, angina pectoris requiring antianginal medication, previous history of
myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or
poorly controlled arterial hypertension (i.e. BP >160 / 90 mm Hg under treatment with
two antihypertensive drugs), rhythm abnormalities requiring permanent treatment,
clinically significant valvular heart disease

7. Evidence for infection including wound infections, HIV, hepatitis

8. History of significant neurological or psychiatric disorders including psychotic
disorders, dementia or seizures that would prohibit the understanding and giving of
informed consent

9. Pre-existing motor or sensory neuropathy of a severity at least grade 1 by NCI-CTC
criteria v 4.0

10. Other severe and relevant co-morbidity that would interact with the application of
cytotoxic agents or the participation in the study

11. Previous or concurrent treatment with:

- concurrent chronic corticosteroids unless initiated > 6 months prior to study
entry and at low dose (less than 10 mg methylprednisolone or equivalent) (except
inhalative corticoids)

- concurrent sex hormones. Prior treatment must be stopped before study entry

- concurrent treatment with any investigational, not marketed drug within 30 days
prior to study entry

- previous or concurrent anti-cancer therapy for any reason

12. Absolute contraindications for the use of corticosteroids

13. Pregnant or lactating patients. Patients of childbearing potential must implement
adequate non-hormonal contraceptive measures (barrier methods, intrauterine
contraceptive devices, sterilization) during study treatment

14. Known hypersensitivity reaction to one of the compounds or incorporated substances
used in this protocol.