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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600249
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : March 20, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Centre Jean Perrin

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Cetuximab Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Primary Outcome Measures :
  1. Pathological complete response assessment of Taxotere-Erbitux combination [ Time Frame: After 18 weeks of treatment ]

Secondary Outcome Measures :
  1. 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) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600249

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.
Principal Investigator: Philippe Chollet, MD Centre Jean Perrin

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Centre Jean Perrin Identifier: NCT00600249     History of Changes
Other Study ID Numbers: TENEO
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action