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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600249
• Other study ID #: TENEO
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2008
• Last updated: March 19, 2014
• Start date: January 2008
• Est. completion date: May 2012

Study information

• Verified date: March 2014
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Cetuximab
dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks
• Docetaxel
100mg/m2 every 21 days 6 cycles of 21 days

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	CHU Albert Michallon	Grenoble
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier	Montluçon
France	Institut de Cancérologie de la LOIRE	Saint Priest en Jarez
France	Hôpital Georges Pianta	Thonon les Bains

Sponsors (3)

Lead Sponsor	Collaborator
Centre Jean Perrin	Merck Sharp & Dohme Corp., Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response assessment of Taxotere-Erbitux combination		After 18 weeks of treatment	Yes
Secondary	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)	Yes