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

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

Official Title
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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

Conditions
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Pathological Response Rate

Intervention / Treatment
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* Drug: vectibix
* Drug: fluorouracile
* Drug: Epirubicine
* Drug: cyclophosphamide
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vectibix|9mg/kg at D1 of each 21-days cycle|
|Drug: fluorouracile|500 mg/m2 at D1 of each 21-days cycle|
|Drug: Epirubicine|100 mg/m2 at D1 of each 21-days cycle|
|Drug: cyclophosphamide|500 mg/m2 at D1 of each 21 dyas cycle|
|Drug: docetaxel|100 mg/m2 at D1 of each 21 days cycle|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the rate of complete histological response, according to Chevallier's classification |  | after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of complete histological response, according to Sataloff's classification; the rate of clinical, ultrasound, mammogram response, according to the WHO criteria; progression-free and overall survival; the tolerance. |  | After 24 weeks of treatment, at surgery and at five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant therapies, chemotherapy, targeted therapy