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

Phase II Pilot Study Evaluating the Neoadjuvant Combination Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and Triple Negative Breast Cancer Patients. TENEO Study.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00600249

Enrollment

Registered

2008-01-24

Start date

2008-01-31

Completion date

2012-05-31

Last updated

2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

DRUGCetuximab

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

DRUGDocetaxel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pathological complete response assessment of Taxotere-Erbitux combination	After 18 weeks of treatment

Secondary

Measure	Time frame
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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026