Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Pathological complete response assessment of Taxotere-Erbitux combination [ Time Frame: After 18 weeks of treatment ]
Secondary Outcome Measures :
Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments [ Time Frame: After 18 weeks of treatment, at surgery and at five years (survival) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
§ 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.
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.