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CompletedNCT00600249Updated Mar 20, 2014

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

A Phase 2 interventional study of Cetuximab and Docetaxel in Breast Cancer, sponsored by Centre Jean Perrin. Completed at 6 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-20.

Sponsored by Centre Jean Perrin · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast cancer.
  • Triple negative.
  • Neoadjuvant chemotherapy.
  • Targeted therapy.
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 35 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Interventions

  • DrugCetuximab

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

    Also known as: Current sponsor code: EMD271786

  • DrugDocetaxel

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

    Also known as: CAS: 148408-66-6

06

What researchers measure

Primary outcomes

  1. Pathological complete response assessment of Taxotere-Erbitux combination

    Time frame: 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

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

07

Study locations

6 sites
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • CHU Albert Michallon
    Grenoble, 38043, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • Centre Hospitalier
    Montluçon, 03113, France
  • Institut de Cancérologie de la LOIRE
    Saint Priest en Jarez, 42270, France
  • Hôpital Georges Pianta
    Thonon les Bains, 74203, France
08

References and documents

Publications

  • 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. PubMed 26649807 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00600249
Lead sponsor
Centre Jean Perrin
Collaborators
Merck Sharp & Dohme LLC, Sanofi
Responsible party
Sponsor
First posted
Jan 24, 2008
Start date
Jan 2008
Primary completion
May 2012
Completion
May 2012
Last update
Mar 20, 2014

Study contacts

Philippe Chollet, MD
principal investigator · Centre Jean Perrin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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