Clinical trial NCT00600249: Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-targeted Therapy" in Breast Cancer.
Official title: Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast cancer.
Triple negative.
Neoadjuvant chemotherapy.
Targeted therapy.
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Sanofi
First posted: 2008-01-24
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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".


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.
* 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.

Primary outcomes:
measure: Pathological complete response assessment of Taxotere-Erbitux combination
timeFrame: After 18 weeks of treatment
Secondary outcomes:
measure: Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments
timeFrame: After 18 weeks of treatment, at surgery and at five years (survival)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Grenoble
country: France
facility: CHU Albert Michallon
city: Lille
country: France
facility: Centre Oscar Lambret
city: Montluçon
country: France
facility: Centre Hospitalier
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie de la LOIRE
city: Thonon les Bains
country: France
facility: Hôpital Georges Pianta
Study officials:
affiliation: Centre Jean Perrin
name: Philippe Chollet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nabholtz JM, Chalabi N, Radosevic-Robin N, Dauplat MM, Mouret-Reynier MA, Van Praagh I, Servent V, Jacquin JP, Benmammar KE, Kullab S, Bahadoor MR, Kwiatkowski F, Cayre A, Abrial C, Durando X, Bignon YJ, Chollet P, Penault-Llorca F. Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer. Int J Cancer. 2016 May 1;138(9):2274-80. doi: 10.1002/ijc.29952. Epub 2015 Dec 28.