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Assessment of the Efficacy of a Neoadjuvant Combination: "Chemotherapy-Targeted Therapy" in Breast Cancer.
This study is not yet open for participant recruitment.
Verified by Centre Jean Perrin, January 2008
First Received: January 14, 2008   No Changes Posted
Sponsors and Collaborators: Centre Jean Perrin
Merck
Sanofi-Aventis
Information provided by: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT00600249
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Cetuximab
Drug: Docetaxel
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Docetaxel Cetuximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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.

Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • Pathological complete response assessment of Taxotere-Erbitux combination [ Time Frame: After 18 weeks of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks
    Drug: Docetaxel
    100mg/m2 every 21 days 6 cycles of 21 days
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600249

Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Hospitalier de la Dracénie
Draguignan, France, 83007
Centre Léon Berard
Lyon, France, 69373
Hopital Nord La Tronche
Grenoble, France, 38043
CHD La Roche-sur-Yon
La Roche-sur-Yon, France, 85925
Sponsors and Collaborators
Centre Jean Perrin
Merck
Sanofi-Aventis
  More Information

No publications provided

Responsible Party: Centre Jean Perrin ( Philippe Chollet )
Study ID Numbers: TENEO
Study First Received: January 14, 2008
Last Updated: January 14, 2008
ClinicalTrials.gov Identifier: NCT00600249     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Jean Perrin:
Breast cancer.
Triple negative.
Neoadjuvant chemotherapy.
Targeted therapy.

Study placed in the following topic categories:
Docetaxel
Skin Diseases
Cetuximab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Cetuximab
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009