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

NCT00600249 | Completed Phase 2

• 1 other identifier: TENEO
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

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".

Conditions

Breast Cancer

Keywords

Breast cancer.; Triple negative.; Neoadjuvant chemotherapy.; Targeted therapy.

Outcome Measures

Primary Outcomes (1)

• Pathological complete response assessment of Taxotere-Erbitux combination

  After 18 weeks of treatment

Secondary Outcomes (1)

• Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments

  After 18 weeks of treatment, at surgery and at five years (survival)

Interventions

Cetuximab DRUG

dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks

Also known as: Current sponsor code: EMD271786

Docetaxel DRUG

100mg/m2 every 21 days 6 cycles of 21 days

Also known as: CAS: 148408-66-6

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• § 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Jean Perrin: lead
• Merck Sharp & Dohme LLC: collaborator
• Sanofi: collaborator

Study Sites (6)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU Albert Michallon

Grenoble, 38043, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier

Montluçon, 03113, France

Location

Institut de Cancérologie de la LOIRE

Saint-Priest-en-Jarez, 42270, France

Location

Hôpital Georges Pianta

Thonon-les-Bains, 74203, France

Location

Related Publications (1)

• Nabholtz JM, Chalabi N, Radosevic-Robin N, Dauplat MM, Mouret-Reynier MA, Van Praagh I, Servent V, Jacquin JP, Benmammar KE, Kullab S, Bahadoor MR, Kwiatkowski F, Cayre A, Abrial C, Durando X, Bignon YJ, Chollet P, Penault-Llorca F. Multicentric neoadjuvant pilot Phase II study of cetuximab combined with docetaxel in operable triple negative breast cancer. Int J Cancer. 2016 May 1;138(9):2274-80. doi: 10.1002/ijc.29952. Epub 2015 Dec 28.

  PMID: 26649807 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cetuximab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Philippe Chollet, MD

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 24, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

FR (6)