Assessment of the Efficacy of a 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 Taxotere-Erbitux.

Official Title
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Phase II Pilot Study Evaluating the Neoadjuvant Combination Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and Triple Negative Breast Cancer Patients. TENEO Study.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Cetuximab
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: § Age > or equal to 18 years.§ Performance status inferior or equal to 1 (WHO criteria) Histologically proven breast cancer, non metastatic, with clinical tumor diameter > or equal to 2 cm. HR negative and HER 2 negative. Clinical stage II and IIIa. Non prior treated patients either by surgery, radiotherapy, hormonotherapy or chemotherapy.§ Adequate hematological, renal and hepatic functions : neutrophils > 2.109 /L, platelets > 100.109 /L, Hb > 10 g/dL, normal bilirubin, ASAT and ALAT inferior or equal to 2,5 ULN (upper normal limit), alkaline phosphatases £ 2,5 ULN, creatinine < 140 µmol/L or creatinine clearance > 60 mL/min.§ Written informed consent§ Affiliation with social security system (or profit being of such a mode) according to terms' of the law of August 9, 2004. Exclusion Criteria: Male patient. Pregnant or lactating women or childbearing potential with no efficacy contraception. Other breast cancer form and particularly inflammatory form and/or negliged (T4b or T4d).§ Non measurable tumor. Prior surgery or primary axillary dissection. Prior treatment for this new breast cancer. Under guardianship patient Patient with antecedent of second cancer, excepted in situ uterine carcinoma or baso-cellular cutaneous cancer considered as definitively cured. Patient with an associated pathology considered incompatible with the study.§ Cardiac, renal, medullar, respiratory or hepatic insufficiency. Significant neurological or psychiatric troubles.§ Symptomatic or evolutive troubles in CNS or metastasis. Peripheral neuropathy > grade 2 NCI-CTC (version 3.0) Previous allergy with polysorbate 80. Concomitant treatment with a drug tested in a clinical trial, participation to another clinical study, for the last thirty days or prior chemotherapy. Patients non stable for the following 6 months or leaving at a great distance of the participating center.

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: Cetuximab|dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks|
|Drug: Docetaxel|100mg/m2 every 21 days 6 cycles of 21 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response assessment of Taxotere-Erbitux combination |  | After 18 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments |  | After 18 weeks of treatment, at surgery and at five years (survival) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer., Triple negative., Neoadjuvant chemotherapy., Targeted therapy.