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

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00600249
• Lead Sponsor: Centre Jean Perrin

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-24
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological complete response assessment of Taxotere-Erbitux combination	After 18 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (6)

Hôpital Georges Pianta; 🇫🇷 Thonon les Bains, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

CHU Albert Michallon; 🇫🇷 Grenoble, France

Centre Hospitalier; 🇫🇷 Montluçon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut de Cancérologie de la LOIRE; 🇫🇷 Saint Priest en Jarez, France