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

Centre Jean Perrin6 sites in 1 country35 target enrollmentJanuary 2008

ConditionsBreast Cancer

DrugsCetuximab Docetaxel

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Centre Jean Perrin
Enrollment: 35
Locations: 6
Primary Endpoint: Pathological complete response assessment of Taxotere-Erbitux combination
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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".

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

May 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Centre Jean Perrin

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Pathological complete response assessment of Taxotere-Erbitux combination

Time Frame: After 18 weeks of treatment

Secondary Outcomes

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))