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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-05-31

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".

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cetuximab

dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks

Intervention Type DRUG

Docetaxel

100mg/m2 every 21 days 6 cycles of 21 days

Intervention Type DRUG

Other Intervention Names

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Current sponsor code: EMD271786 CAS: 148408-66-6

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No