- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00600249
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
Study Type
Interventional
Enrollment (Anticipated)
35
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
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Clermont-Ferrand, France, 63011
- Centre Jean Perrin
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Grenoble, France, 38043
- CHU Albert Michallon
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Lille, France, 59020
- Centre Oscar Lambret
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Montluçon, France, 03113
- Centre Hospitalier
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Saint Priest en Jarez, France, 42270
- Institut de Cancerologie de la Loire
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Thonon les Bains, France, 74203
- Hopital Georges Pianta
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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
No
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
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.
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)
May 1, 2012
Study Registration Dates
First Submitted
January 14, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 24, 2008
Study Record Updates
Last Update Posted (Estimate)
March 20, 2014
Last Update Submitted That Met QC Criteria
March 19, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TENEO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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