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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

18. juli 2013 opdateret af: UNICANCER

Randomized And Multicentric Opened Phase III Study Evaluating The Concomitant Administration Of Docetaxel 75MG/M2 and Epirubicine 75MG/M2 Versus FEC 100 In Non Metastatic With Positive Lymphatic Nodes Breast Cancer Subjects, And The Sequential Addition Of Herceptin In (HER2+++) And (HER2++ And FISH+) Subjects

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer.

PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

  • Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs adjuvant docetaxel and epirubicin, in terms of 5-year survival without relapse, in women with nonmetastatic adenocarcinoma of the breast with lymph node invasion.
  • Determine survival of patients treated with these regimens.
  • Compare the tolerability of trastuzumab (Herceptin) in patients treated with these regimens.
  • Determine the efficacy and tolerability of trastuzumab in patients with hormone receptor-positive tumors.
  • Evaluate the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center. Patients are treated in 2 parts.

  • Part I: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
    • Arm II: Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I.

Patients with HER2/neu-positive tumors then proceed to part II. Patients with HER2/neu-negative tumors receive no further treatment.

Patients with hormone (estrogen or progesterone) receptor-positive tumors also receive oral tamoxifen daily beginning after chemotherapy is completed and continuing for 5 years.

  • Part II: Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes every 3 weeks for 1 year.
    • Arm II: Patients are followed without treatment. Patients not receiving trastuzumab are followed at 4 months, 6 months, every 4 months for 1 year, and then every 6 months for 3 years. Patients receiving trastuzumab are followed at 4 months and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study within 3 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3010

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Angers, Frankrig, 49036
        • Centre Paul Papin
      • Annecy, Frankrig, 74011 Cedex
        • Centre Hospitalier d'Annecy
      • Bordeaux, Frankrig, 33076
        • Institut Bergonie
      • Bourg En Bresse, Frankrig, 01012
        • C.H. Bourg En Bresse
      • Caen, Frankrig, 14076
        • Centre Regional Francois Baclesse
      • Clermont-Ferrand, Frankrig, 63011
        • Centre Jean Perrin
      • Creteil, Frankrig, 94010
        • Hôpital Intercommunal de Créteil
      • Dijon, Frankrig, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Grenoble, Frankrig, 38100
        • Institut Prive de Cancerologie
      • Harfleur, Frankrig, 76700
        • Clinique du Petit Colmouilins
      • Lagny Sur Marne, Frankrig, 77405
        • Centre Hospitalier de Lagny
      • Le Chesnay, Frankrig, 78157
        • Hopital Andre Mignot
      • Le Havre, Frankrig, 76600
        • CMC Les Ormeaux
      • Marseille, Frankrig, 13273
        • Institut J. Paoli and I. Calmettes
      • Metz, Frankrig, 57038
        • Centre Hospitalier Regional Metz Thionville
      • Montbeliard, Frankrig, 25209
        • Centre Hospitalier General Andre Boulloche
      • Montpellier, Frankrig, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Mulhouse, Frankrig, 68051
        • Centre Hospitalier de Mulhouse
      • Nantes-Saint Herblain, Frankrig, 44805
        • Centre Regional Rene Gauducheau
      • Paris, Frankrig, 75674
        • Hôpital Avicenne
      • Perpignan, Frankrig
        • Clinique Saint - Pierre
      • Poitiers, Frankrig, 86021
        • CHU Poitiers
      • Reims, Frankrig, 51056
        • Institut Jean Godinot
      • Rennes, Frankrig, 35042
        • Centre Eugene Marquis
      • Sainte Clotilde, Frankrig, 97492
        • Clinique sainte Clotilde
      • Strasbourg, Frankrig, 67065
        • Centre Paul Strauss
      • Strasbourg, Frankrig, 67091
        • Hopitaux Universitaire de Strasbourg
      • Toulouse, Frankrig, 31052
        • Institut Claudius Regaud
      • Villejuif, Frankrig, F-94805
        • Institut Gustave Roussy

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 64 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed nonmetastatic, unilateral adenocarcinoma of the breast

    • Axillary lymph node invasion (N1, N2, or N3)
    • No cutaneous invasion
    • No T4a or greater disease
  • No clinically or radiologically suspected metastases
  • No clinically or radiologically suspected contralateral lesion
  • No deeply adherent or inflammatory disease
  • Complete surgical resection performed, including removal of at least 5 lymph nodes, and with no residual tumor, within the past 42 days
  • No prior breast cancer

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 to 64

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • ALT and AST no greater than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • Bilirubin no greater than ULN
  • Hepatitis B and hepatitis C negative
  • No hepatic dysfunction

Renal

  • Creatinine less than 1.3 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • ECHO normal
  • LVEF at least 50%

Pulmonary

  • FEV normal
  • No dyspnea at rest
  • No supplemental oxygen dependence

Other

  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No contraindication to anthracycline therapy
  • No chronic medical or psychological condition
  • No geographic or social reason that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 4 weeks since prior chemotherapy
  • No other concurrent chemotherapy
  • No contraindication to anthracycline therapy

Endocrine therapy

  • No prior hormonal therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 4 weeks since prior experimental therapy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 6 FEC
Patients receive fluorouracil IV, or epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy 5 days a week for 5 weeks.
Biologisk: Trastuzumab
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
Andre navne:
  • Herceptin
Medicin: Cyclophosphamide
500 mg/m², D1 and every 3 weeks
Medicin: Epirubicin
100 mg/m², D1 and every 3 weeks
Andre navne:
  • epirubicin hydrochlorid
Medicin: Fluorouracil
500 mg/m², D1 and every 3 weeks
Eksperimentel: 6 DE
Patients receive epirubicin IV over 10 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses. Patients then undergo radiotherapy as in arm I
Biologisk: Trastuzumab
8 mg/kg at month M6, followed by a maintenance dose of 6 mg/kg every 3 weeks for a 1 year (i.e. 18 injections in total)
Andre navne:
  • Herceptin
Medicin: Epirubicin
100 mg/m², D1 and every 3 weeks
Andre navne:
  • epirubicin hydrochlorid
Medicin: docetaxel
on day D1 of each cycle : dose: 75 mg/m², route: i.v. injection over 1 hour, every 3 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression Free Survival
Tidsramme: 5 years from randomization
5 years from randomization

Sekundære resultatmål

Resultatmål
Tidsramme
Herceptin safety
Tidsramme: 5 years from randomization
5 years from randomization
Overall survival
Tidsramme: 5 years from randomization
5 years from randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UNICANCER

Efterforskere

  • Studiestol: Marc Spielmann, MD, Gustave Roussy, Cancer Campus, Grand Paris

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2001

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. december 2009

Datoer for studieregistrering

Først indsendt

5. februar 2003

Først indsendt, der opfyldte QC-kriterier

5. februar 2003

Først opslået (Skøn)

6. februar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UC-0140/0005 - PACS 04
  • FRE-FNCLCC-PACS-04/0005
  • EU-20236
  • PACS04 (Anden identifikator: UNICANCER)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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