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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

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

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Pathological complete response assessment of Taxotere-Erbitux combination

Outcome Time Frame:

After 18 weeks of treatment

Safety Issue:


Principal Investigator

Philippe Chollet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Jean Perrin


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2008

Completion Date:

November 2012

Related Keywords:

  • Breast Cancer
  • Breast cancer.
  • Triple negative.
  • Neoadjuvant chemotherapy.
  • Targeted therapy.
  • Breast Neoplasms