Clinical trial · Interventional
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.
NCT00600249CI-TRIAL-00014077completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathological complete response assessment of Taxotere-Erbitux combination
- timeFrame
- After 18 weeks of treatment
Secondary outcomes (1)
- measure
- Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments
- timeFrame
- After 18 weeks of treatment, at surgery and at five years (survival)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDNabholtz 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