Text Size

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

This study is currently recruiting participants.
Verified August 2012 by Centre Jean Perrin
Sponsor:
Collaborators:
Merck
Sanofi
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT00600249
First received: January 14, 2008
Last updated: August 2, 2012
Last verified: August 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

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: November 2012
Estimated Primary Completion Date: November 2012 (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
    Other Name: Current sponsor code: EMD271786
    Drug: Docetaxel
    100mg/m2 every 21 days 6 cycles of 21 days
    Other Name: CAS: 148408-66-6
  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

Contacts
Contact: Jean-Marc NABHOLTZ, MD (33) 4 73 27 84 99 Jean-Marc.NABHOLTZ@cjp.fr
Contact: Catherine ABRIAL, PhD (33) 4 73 27 84 91 Catherine.ABRIAL@cjp.fr

Locations
France
Centre Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Contact: Jean-Marc Nabholtz, MD     (33) 4 73 27 84 99     Jean-Marc.NABHOLTZ@cjp.fr    
Contact: Catherine Abrial, PhD     (33) 4 73 27 80 05     Catherine.ABRIAL@cjp.fr    
Principal Investigator: Philippe Chollet, MD            
Sub-Investigator: Marie-Ange Mouret-Reynier, MD            
Sub-Investigator: Xavier Durando, MD, PhD            
Sub-Investigator: Isabelle VAN PRAAGH, MD            
Sub-Investigator: Jean-Pierre Ferrière, MD            
Sub-Investigator: Jean-Marc Nabholtz, MD            
Sub-Investigator: Pascale Dubray-Longeras, MD            
Sub-Investigator: Béatrice Nayl, MD            
Sub-Investigator: Daniela Burlacu, MD            
CHU Albert Michallon Active, not recruiting
Grenoble, France, 38043
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Véronique Servent, MD     (33) 3 20 29 59 43     v-servent@o-lambret.fr    
Principal Investigator: Véronique Servent, MD            
Sub-Investigator: Laurence Vanlemmens, MD            
Sub-Investigator: Jacques Bonneterre, MD            
Sub-Investigator: Anne Lesoin, MD            
Sub-Investigator: Audrey Mailliez, MD            
Sub-Investigator: Anne Donnadieu, MD            
Sub-Investigator: Philippe Vennin, MD            
Centre Hospitalier Recruiting
Montluçon, France, 03113
Contact: Jean-Marc Nabholtz, MD         Jean-Marc.NABHOLTZ@cjp.fr    
Principal Investigator: Jean-Marc Nabholtz, MD            
Sub-Investigator: Jean-Pierre Ferrière, MD            
Sub-Investigator: Béatrice Nayl, MD            
Institut de Cancérologie de la LOIRE Recruiting
Saint Priest en Jarez, France, 42270
Contact: Jean-Philippe Jacquin, MD     (33) 4 77 91 70 25     jean-philippe.jacquin@icloire.fr    
Principal Investigator: Jean-Philippe Jacquin, MD            
Hôpital Georges Pianta Recruiting
Thonon les Bains, France, 74203
Contact: Francesco Del Piano, MD     (33) 4 50 83 20 65     f-delpiano@ch-hopitauxduleman.fr    
Principal Investigator: Francesco Del Piano, MD            
Sponsors and Collaborators
Centre Jean Perrin
Merck
Sanofi
Investigators
Principal Investigator: Philippe Chollet, MD Centre Jean Perrin
  More Information

No publications provided

Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT00600249     History of Changes
Other Study ID Numbers: TENEO
Study First Received: January 14, 2008
Last Updated: August 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013