Breast Cancer Treated by Neoadjuvant Chemotherapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Centre Jean Perrin.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT00425516
First received: January 22, 2007
Last updated: February 26, 2007
Last verified: February 2007
  Purpose

Neoadjuvant chemotherapy, known as "first" or "induction chemotherapy" in the therapeutic assumption of breast cancer is based on the narrow dependence preclinically revealed between primary tumour, tumoral angiogenesis and growth of distant metastases.

The results of the Aberdeen Group (Smith et al, 2002 ; Hutcheon et al, 2003), of the NSABP B27 trial (Bear et al, 2003) and of the Gepar-Duo Group (Von Minckwitz et al, 2002) have shown that a sequential protocol, using docetaxel after an anthracycline-based combination, allowed a better clinical response leading to more frequent conservative surgeries and, more importantly, to an increase in the rate of complete pathological response, assessing a better efficacy.

The use of a reference adjuvant protocol as a neo-adjuvant treatment is fully admissible because 7 randomized trials have shown a perfect equivalence between an adjuvant protocol and the same chemotherapy given as an induction treatment Even keeping the principle of a sequential treatment, a crucial question is to know if this sequential treatment should be the same for all patients, or if the oncologist could get a better complete pathological response, disease-free or overall survival rates by an adaptation of treatment to the objective result beginning after 2 FEC 100 courses by modulation of the following courses.

We will use as a primary regimen 3 FEC cycles + 3 TAXOTERE cycles, a standard adjuvant regimen (noted in the Temporary Protocol of Treatment of the Inca page 5 (October 2005) as well as in Saint Paul de Vence 2005 recommendations for adjuvant chemotherapy (Oncologie –– volume 7 – N°5, August 2005, p 370). This standard treatment will be compared to the same chemotherapy modulated in its repartition according to results obtained by subsequent tumor evaluations during induction therapy.


Condition Intervention Phase
Breast Cancer
Drug: Taxotere
Drug: 5-Fluorouracil
Drug: Epirubicin
Drug: Cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of the Neoadjuvant Standard Chemotherapy 3 FEC 100 + 3 TAXOTERE Protocol Versus the Same Protocol Adapted as a Function of Clinical Response

Resource links provided by NLM:


Further study details as provided by Centre Jean Perrin:

Primary Outcome Measures:
  • Improvement of complete pathological response rate at surgery after 6 chemotherapy cycles

Secondary Outcome Measures:
  • Tolerance according to NCI-CTC criteria
  • Objective clinical, echographic, mammographic responses after 6 cycles
  • Breast conservation rate
  • Study of biological predictive factors of chemosensitivity and resistance by immunological and molecular biology techniques)
  • Overall and relapse-free survivals

Estimated Enrollment: 264
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with histological proof of non metastatic breast cancer, whose clinical tumor diameter is > 2 cm, or < 2 cm, but situated in areolar area of the nipple.
  • T2-T3, N0-N1 tumor, non-inflammatory, unilateral, non-metastatic, grade II – III, HER2-neu negative, without extension beyond the breast and axillar area.
  • Performance Status = 0-1 WHO.
  • Patient non pretreated for breast cancer.
  • Patient without cardiac pathology and without anthracyclines contra-indication (assessed by normal ejection fraction).
  • Normal haematological, renal and hepatic functions : PNN > 2.109 /l, platelets > 100. 109 /l, Hb > 10 g/dl, normal bilirubin serum , ASAT and ALAT < 2,5 ULN, alkaline phosphatases < 2,5 ULN, creatinin < 140 µmol/l or creatinin clearance > 60 ml/min
  • Written informed consent dated and signed by the patient

Exclusion Criteria:

  • All other breast cancers than those described in inclusion criteria, in particular inflammatory and/or neglected (T4b or T4d) forms.
  • Patient presenting with plurifocal tumors, multicentric tumor, bilateral tumor.
  • Grade I well differentiated tumor.
  • HER2 neu 3 + (ICH or FISH or CISH) tumor.
  • Non measurable lesion, in the two diameters, whatever radiological methods used.
  • Patient presenting microcalcifications for which breast conservation is not possible.
  • Patient already operated for breast cancer or having had primary axillar node dissection.
  • Patient having antecedent of other cancer, exception for in situ uterine cervix or basocellular skin cancer, considered as healed.
  • Patient presenting another pathology considered as incompatible with patient inclusion in the study
  • Patient should not receive treatment with any other investigational drug and should not participate to another clinical study in a delay < 30 days or should not be pre-treated by cytostatic chemotherapy.
  • Antecedents of allergy to polysorbate 80.
  • Patient who is pregnant or lactating and not using effective contraceptive method.
  • Any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow up schedule, assessed with the patient prior to registration in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425516

Contacts
Contact: Philippe Chollet, Pr +33 (0)4 73 27 80 05 Philippe.Chollet@cjp.fr

Locations
France
Hospital center Not yet recruiting
Brive La Gaillarde, France, 19100
Contact: Bernard Leduc, Dr    +33 (0)5 55 92 66 70    bernard.leduc@ch-brive.fr   
Principal Investigator: Bernard Leduc, Dr         
Sub-Investigator: Isabelle Sillet-Bach, Dr         
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Contact: Philippe Chollet, Pr    +33 (0)4 73 27 80 05    Philippe.Chollet@cjp.fr   
Principal Investigator: Philippe Chollet, Pr         
Sub-Investigator: Xavier Durando, Dr         
Sub-Investigator: Jean Pierre Ferriere, Dr         
Sub-Investigator: Marie Ange Mouret-Reynier, Dr         
Sub-Investigator: Marie Françoise Mazen, Dr         
Sub-Investigator: Isabelle Van Praagh, Dr         
Sub-Investigator: Marianne Leheurteur, Dr         
Sub-Investigator: Véronique Boussion, Dr         
Sub-Investigator: Sophie Poujol, Dr         
University Hospital La Tronche Not yet recruiting
Grenoble, France, 38043
Contact: Mireille Mousseau, Dr    +33 (0)4 76 76 54 36    Mmousseau@chu-grenoble.fr   
Principal Investigator: Mireille Mousseau, Dr         
Edouard Herriot University Hospital Not yet recruiting
Lyon, France, 69000
Contact: Jean Dominique Tigaud, Dr    +33 (0)4 72 11 95 18    jean-dominique.tigaud@chu-lyon.fr   
Principal Investigator: Jean Dominique Tigaud         
Institut Jean Godinot Not yet recruiting
Reims, France, 51056
Contact: Hervé Curé, Pr    +33 (0)3 26 50 44 87    herve.cure@reims.fnclcc.fr   
Principal Investigator: Hervé Curé, Pr         
Sub-Investigator: Brigitte Costa, Dr         
Sub-Investigator: J. Christophe Eymard, Dr         
Sub-Investigator: Christelle Jouannaud, Dr         
Sub-Investigator: Daniela Lebrun, Dr         
Sub-Investigator: Louis Michel Caquot, Dr         
Institut de Cancérologie de la Loire Not yet recruiting
Saint Priest en Jarez, France, 42270
Contact: J. Philippe Jacquin, Dr    +33 (0)4 77 91 70 25    jean.philippe.jacquin@icloire.fr   
Principal Investigator: Jean Philippe Jacquin, Dr         
Sub-Investigator: Guillaume Clavreul, Dr         
Sub-Investigator: D Mille, Dr         
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Study Chair: Philippe Chollet, Pr Centre Jean Perrin
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00425516     History of Changes
Other Study ID Numbers: CJP AU651/Afssaps060744
Study First Received: January 22, 2007
Last Updated: February 26, 2007
Health Authority: France: Ministry of Health

Keywords provided by Centre Jean Perrin:
neoadjuvant chemotherapy
breast cancer
sequential treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on April 17, 2014