Assessment of the Efficacy of the Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.

Phase II Trial Assessing Neoadjuvant Therapy With FEC 100 Followed by Taxotere® (Docetaxel) Plus Vectibix® (Panitumumab) in Patients With Operable, HR and Her-2 Negative Breast Cancer. TVA Study

The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination: "FEC-Taxotere/Vectibix".

Inclusion Criteria:

• Age ³ 18.- Performance status £ 2 (according to WHO criteria).
• Patient has histologically confirmed, non-metastatic breast cancer, with a clinical tumour diameter of ³ 2 cm
• HR negative and Her-2 negative.
• Clinical stage II and IIIa.
• Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy.· Haematology: o Neutrophil count ≥1.5x109/Lo Platelet count ≥100x109/Lo Leucocyte count > 3,000/mmo Hb> 9g/dl· Hepatic Function:o Total bilirubin ≤ 1.5 time the upper normal limit (UNL)o ASAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases ALAT ≤ 2.5xUNL in absence of liver metastases, or ≤5xUNL in presence of liver metastases Alkaline phosphatase ≤ 2.5 time the upper normal limit (UNL)· Renal Function· Creatinine clearance ≥50 mL/min and serum creatinine ≤1.5xUNL· Metabolic Function o Magnesium ≥ lower limit of normal. o Calcium ≥ lower limit of normal.
• Patient with no progressive heart disease, and for whom anthracyclines are not contraindicated (normal FEV).
• Patient has signed the consent forms for participation before inclusion in the trial.
• Member of a Social Security scheme (or a beneficiary of such a scheme) according to the provisions of the law of 9 August 2004.

Exclusion Criteria:

• Male patients.
• Her-2 positive patients
• Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
• Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
• Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d).
• Non-measurable tumour.
• Patients have already undergone surgery for their disease or have had primary axillary dissection.
• Patient has already been treated for new breast cancer.
• Patient is a ward.
• 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 another disease which is deemed incompatible with the patient being included in the protocol.
• Heart or kidney failure, medullary, respiratory or liver failure.
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) £ 1 year before enrollment/randomization
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
• 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 (NCI-CTCAE criteria, Version 3.0).
• History of allergy to polysorbate 80.
• Concomitant treatment with a trial drug, participation in another clinical trial within < 30 days or previous chemotherapy.
• Patient with no fixed address in the next 6 months or living at a distance from the treatment centre so it is difficult to check her progress.
• Prior anti-EGFr antibody therapy (e.g.:cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g.: erlotinib).
• Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
• Any investigational agent within 30 days before initiation of study treatment. - Must not have had a major surgical procedure within 28 days of initiation of treatment.
• Subject unwilling or unable to comply with study requirements.