Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer

Inclusion Criteria:

* Female patients aged 18-70 years.
* Diagnosed with locally advanced (T2-3, N2-3, M0 or T4a-c, any N, M0), inflammatory (T4d, any N, M0) or operable (T2-3, N0-1, M0), invasive breast cancer.
* Primary tumor \> 2 cm in diameter.
* HER2 positive breast cancer confirmed (Tumors must be IHC 3+ or FISH/CISH + for IHC 2+ tumors).
* Baseline LVEF ≥ 55% measured by echocardiography.
* Performance status ECOG ≤ 1
* Signed informed consent.

Exclusion Criteria:

* Metastatic disease (Stage IV) or bilateral breast cancer.
* Previous anticancer therapy or radiotherapy for any malignancy.
* Other malignancy, except for carcinoma in situ of the cervix or basal cell carcinoma.
* Received any investigational treatment within 4 weeks of study start.
* At least 4 weeks since major surgery.
* Uncontrolled hypertension (systolic \> 150 and/or diastolic \> 100), unstable angina, CHF of any NYHA classification, serious cardiac arrhythmia requiring treatment, history of myocardial infarction within 6 months of enrollment.
* Hematological, biochemical and organ dysfunction:

  1. Inadequate bone marrow function: Absolute Neutrophil Count (ANC) \< 1500 cells/ µL, Platelet count \< 100,000 cells/ µL and Hb \< 9 g/dL).
  2. Impaired liver function: serum \[total\] bilirubin \> 1.25 x ULN, AST/ALT \> 1. 5 x ULN with ALP \> 2.5 x ULN
  3. Inadequate renal function: serum creatinine \> 1.5 x ULN.
* Dyspnea at rest or other diseases which require continuous oxygen therapy.
* Severe uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, metabolic, etc).
* Current chronic daily treatment with corticosteroids (dose of ≥10 mg Oral prednisolone, or equivalent \[excluding inhaled steroids\])
* Subjects with known infection with HIV, HBV, and HCV.
* Known hypersensitivity to any of the study drugs or excipients.
* Pregnant and/or lactating women or subjects with reproductive potential not willing to use effective methods of contraception.
* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)