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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Jean Perrin
• Collaborators: Merck Sharp & Dohme Corp.; Sanofi
• Treatments: Cetuximab; Docetaxel

Criteria

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.