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