Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

Inclusion criteria

• Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive breast cancer,
• Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
• Any N,
• No evidence of metastasis (M0);
• Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:
• 3+ over expression by immunohistochemistry (IHC) (> 30% of invasive tumour cells),
• 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,
• Her 2 gene amplication by FISH/CISH (ratio > 2.2);
• Known hormone receptor status
• Hematopoietic status:

• absolute neutrophil count ≥ 1.5 x 109/L,
• platelet count ≥ 100 x 109/L,
• Hepatic status:

• serum total bilirubin ≤ 1.5 x ULN. In the case of known Gilbert's syndrome a higher serum total bilirubin (< 2 x ULN) is allowed,
• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,
• alkaline phosphatase ≤ 2.5 times ULN;
• Renal status:

a. Creatinine ≤ 2.0 mg/dL;

• Cardiovascular:

a. baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA);

• For women of childbearing potential negative serum pregnancy test
• Written informed consent.

Exclusion criteria

• Male gender
• Pregnant or lactating women
• Received any prior treatment for primary invasive breast cancer
• Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic therapy with oxygen;
• Active or uncontrolled infection,
• Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
• Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
• Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
• Concurrent disease or condition that would have make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety.