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

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Sanofi
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT00600249
First received: January 14, 2008
Last updated: March 19, 2014
Last verified: March 2014
  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:


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
Study Completion Date: May 2012
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600249

Locations
France
Centre Jean Perrin
Clermont-Ferrand, France, 63011
CHU Albert Michallon
Grenoble, France, 38043
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier
Montluçon, France, 03113
Institut de Cancérologie de la LOIRE
Saint Priest en Jarez, France, 42270
Hôpital Georges Pianta
Thonon les Bains, France, 74203
Sponsors and Collaborators
Centre Jean Perrin
Merck Sharp & Dohme Corp.
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: March 19, 2014
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 July 29, 2014