Breast Cancer Treated by Neoadjuvant Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Jean Perrin
ClinicalTrials.gov Identifier:
NCT00425516
First received: January 22, 2007
Last updated: September 30, 2014
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
Individualized Chemotherapy
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 [ Time Frame: after 6 cycles of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance according to NCI-CTC criteria [ Time Frame: after each cycle of chemotherapy ] [ Designated as safety issue: Yes ]
  • Objective clinical, echographic, mammographic responses after 6 cycles [ Time Frame: after every 2 cycles of chemotherapy treatment ] [ Designated as safety issue: No ]
  • Breast conservation rate [ Time Frame: at surgery ] [ Designated as safety issue: No ]
  • Study of biological predictive factors of chemosensitivity and resistance by immunological and molecular biology techniques) [ Time Frame: before receive chemotherapy ] [ Designated as safety issue: No ]
  • Overall and relapse-free survivals [ Time Frame: 5 years after diagnosis ] [ Designated as safety issue: No ]

Enrollment: 264
Study Start Date: January 2007
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard (A)
3 FEC100 followed 3 Taxotere
Experimental: Modulated (B)
possibility treatments receive: 2 FEC100 followed by 4 Taxotere 4 FEC100 followed by 2 Taxotere 6 FEC 100
Drug: Taxotere
Other Name: Docetaxel
Drug: 5-Fluorouracil Drug: Epirubicin Drug: Cyclophosphamide

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425516

Locations
France
Hospital center
Brive La Gaillarde, France, 19100
Centre Jean Perrin
Clermont Ferrand, France, 63011
University Hospital La Tronche
Grenoble, France, 38043
Edouard Herriot University Hospital
Lyon, France, 69000
Institut Jean Godinot
Reims, France, 51056
Institut de Cancérologie de la Loire
Saint Priest en Jarez, France, 42270
Sponsors and Collaborators
Centre Jean Perrin
Investigators
Study Chair: Philippe Chollet, Pr Centre Jean Perrin
  More Information

Publications:
Responsible Party: Centre Jean Perrin
ClinicalTrials.gov Identifier: NCT00425516     History of Changes
Other Study ID Numbers: CJP AU651/Afssaps060744
Study First Received: January 22, 2007
Last Updated: September 30, 2014
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Cyclophosphamide
Fluorouracil
Docetaxel
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on October 19, 2014