Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status

Inclusion Criteria: * Women aged ≥ 18; * Patient has histologically confirmed breast cancer, with a clinical tumour diameter of \> 1 cm (cT1c, cT2-3 or T4a)- * Any N status * No clinically or radiologically detectable metastases (M0); * HR negative (both ER and PR \< 10% by IHC); for T1c status, otherwise HR negative or positive * Her-2 positive (i.e. IHC score 3+ or FISH/SISH/CISH positive); * Performance status ≤ 1 (according to WHO criteria); * Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy; * Hæmatology: Absolute neutrophil count (ANC) ≥1,500/mm³; Platelets ≥100,000/mm³; Total white blood cell count (WBC) ≥3.000/mm³; Hb\> 9g/dl; * Hepatic Function: Total bilirubin ≤1.5 time the upper normal limit (UNL); ASAT ≤ 1.5xUNL; ALAT ≤ 1.5xUNL; Alkaline phosphatase ≤ 2.5xUNL; * Renal Function: Serum creatinine ≤1.5xUNL (and if Serum creatinine \>1.5xUNL, Creatinine clearance ≥50 mL/min (MDRD formula); * Metabolic Function: Magnesium ≥ lower limit of normal; Calcium ≥ lower limit of normal; * Patient with not controlled heart disease and for whom anthracyclines are not contraindicated. Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion; * Patient agreeing to use effective contraception during and for ≥ 7 months after completion of study treatment; * Patient able to comply with the protocol; * Patient must have signed a written informed consent form prior to any study specific procedures; * Patient must be affiliated to a Social Health Insurance. Exclusion Criteria: * Bilateral or multifocal breast cancer; * Non-measurable tumour; * Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d); * HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative); * RH positive (ER or PR ≥ 10% by IHC) ; * Patient has a history of second cancer, with exception of in situ cervical cancer or basocellular skin cancer which is regarded as cured; * Patient has already been treated for new breast cancer; * Patients have already undergone surgery for their disease or have had primary axillary dissection; * Prior docetaxel administration or anti-HER2 antibody therapy (e.g.: trastuzumab or pertuzumab); * Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to: * Heart or kidney failure, medullary, respiratory or liver failure, dyspnea * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, poorly controlled hypertension) ≤ 1 year before enrollment * Uncontrolled diabetes * Significant neurological or psychiatric abnormalities * Symptomatic or progressive disorder of the central nervous system (CNS) or metastasis at the initial check-up. * Peripheral neuropathy \> grade 2 * Acute urinary infection, ongoing hemorrhagic cystitis; * Patients with a known history of HIV seropositivity; * Sensitivity to any of the study medications or any of the ingredients or excipients of these medications; * Patients receiving of the concomitant medications with phenytoin; * Patients who received any other investigational drugs within 30 days of initiation of treatment and/or during the study; * Must not have had a major surgical procedure within 30 days of initiation of treatment; * Pregnant women, women who are likely to become pregnant or are breast-feeding; * Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; * Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol; * Individual deprived of liberty or placed under the authority of a tutor.