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

March 19, 2014 updated by: Centre Jean Perrin

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

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

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Clermont-Ferrand, France, 63011
    - Centre Jean Perrin
  - Grenoble, France, 38043
    - Chu Albert Michallon
  - Lille, France, 59020
    - Centre Oscar Lambret
  - Montluçon, France, 03113
    - Centre hospitalier
  - Saint Priest en Jarez, France, 42270
    - Institut de Cancérologie de la Loire
  - Thonon les Bains, France, 74203
    - Hôpital Georges PIANTA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response assessment of Taxotere-Erbitux combination Time Frame: After 18 weeks of treatment	After 18 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	After 18 weeks of treatment, at surgery and at five years (survival)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Jean Perrin

Collaborators

Sanofi

Merck Sharp & Dohme LLC

Investigators

Principal Investigator: Philippe Chollet, MD, Centre Jean Perrin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)