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Chemotherapy Plus Monoclonal Antibody Therapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Overexpresses HER2

31. maj 2013 opdateret af: National Cancer Institute (NCI)

Pilot Trial of Paclitaxel-Herceptin Adjuvant Therapy for Early Stage Breast Cancer

Randomized phase II trial to study the effectiveness of chemotherapy with paclitaxel and the monoclonal antibody trastuzumab followed by chemotherapy in treating women who have stage II or stage IIIA breast cancer that overexpresses HER2. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

Studieoversigt

Status

Afsluttet

Betingelser

Brystkræft

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

I. Evaluate the safety of paclitaxel plus trastuzumab (Herceptin) followed by adjuvant chemotherapy in women with node positive stage II or IIIa breast cancer with HER2 overexpression.

II. Evaluate the safety of long term trastuzumab (Herceptin) in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy (none planned vs planned to breast or chest wall). Patients are randomized to one of two treatment arms.

ARM I: Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab (Herceptin) repeats weekly for 10 courses. At 3 weeks following paclitaxel and trastuzumab (Herceptin), patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses. Following chemotherapy, estrogen receptor (ER) positive and/or progesterone receptor (PR) positive patients receive oral tamoxifen twice daily for 5 years.

ARM II: Patients receive same therapy as in Arm I, except for additional trastuzumab (Herceptin) IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year. ER and/or PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab (Herceptin). Following completion of doxorubicin and cyclophosphamide, post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 1 year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- California
  - Palo Alto, California, Forenede Stater, 94304
    - Veterans Affairs Medical Center - Palo Alto
  - Stanford, California, Forenede Stater, 94305-5408
    - Stanford University Medical Center
- Colorado
  - Denver, Colorado, Forenede Stater, 80209-5031
    - CCOP - Colorado Cancer Research Program, Inc.
- Florida
  - Tampa, Florida, Forenede Stater, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30322
    - Emory University Hospital - Atlanta
  - Decatur, Georgia, Forenede Stater, 30033
    - Veterans Affairs Medical Center - Atlanta (Decatur)
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  - Chicago, Illinois, Forenede Stater, 60611
    - Veterans Affairs Medical Center - Chicago (Lakeside)
  - Decatur, Illinois, Forenede Stater, 62526
    - CCOP - Central Illinois
  - Evanston, Illinois, Forenede Stater, 60201
    - CCOP - Evanston
  - Peoria, Illinois, Forenede Stater, 61602
    - CCOP - Illinois Oncology Research Association
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Veterans Affairs Medical Center - Indianapolis (Roudebush)
- Iowa
  - Cedar Rapids, Iowa, Forenede Stater, 52403-1206
    - CCOP - Cedar Rapids Oncology Project
- Kansas
  - Wichita, Kansas, Forenede Stater, 67214-3882
    - CCOP - Wichita
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70121
    - CCOP - Ochsner
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21231
    - Johns Hopkins Oncology Center
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02215
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, Forenede Stater, 02111
    - New England Medical Center Hospital
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - CCOP - Ann Arbor Regional
  - Kalamazoo, Michigan, Forenede Stater, 49007-3731
    - CCOP - Kalamazoo
- Minnesota
  - Rochester, Minnesota, Forenede Stater, 55905
    - Mayo Clinic Cancer Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
- Nebraska
  - Omaha, Nebraska, Forenede Stater, 68131
    - CCOP - Missouri Valley Cancer Consortium
- New Jersey
  - Elizabeth, New Jersey, Forenede Stater, 07201
    - Trinitas Hospital - Jersey Street Campus
  - Flemington, New Jersey, Forenede Stater, 08822
    - Hunterdon Regional Cancer Program
  - Hackensack, New Jersey, Forenede Stater, 07601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, Forenede Stater, 07601
    - CCOP - Northern New Jersey
  - Morristown, New Jersey, Forenede Stater, 07962-1956
    - Morristown Memorial Hospital
- New York
  - Albany, New York, Forenede Stater, 12208
    - Veterans Affairs Medical Center - Albany
  - Bronx, New York, Forenede Stater, 10461
    - Albert Einstein Comprehensive Cancer Center
  - New York, New York, Forenede Stater, 10016
    - Kaplan Cancer Center
  - New York, New York, Forenede Stater, 10010
    - Veterans Affairs Medical Center - New York
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester Cancer Center
- North Dakota
  - Fargo, North Dakota, Forenede Stater, 58122
    - CCOP - Merit Care Hospital
- Ohio
  - Cleveland, Ohio, Forenede Stater, 44106-5065
    - Ireland Cancer Center
- Oklahoma
  - Tulsa, Oklahoma, Forenede Stater, 74136
    - CCOP - Sooner State
- Pennsylvania
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - University of Pennsylvania Cancer Center
  - Wynnewood, Pennsylvania, Forenede Stater, 19096
    - CCOP - MainLine Health
- Tennessee
  - Nashville, Tennessee, Forenede Stater, 37232-6838
    - Vanderbilt Cancer Center
- Wisconsin
  - Madison, Wisconsin, Forenede Stater, 53705
    - Veterans Affairs Medical Center - Madison
  - Madison, Wisconsin, Forenede Stater, 53792
    - University of Wisconsin Comprehensive Cancer Center
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, Forenede Stater, 53295
    - Veterans Affairs Medical Center - Milwaukee (Zablocki)
Sydafrika
- - Pretoria, Sydafrika, 0001
    - Pretoria Academic Hospital

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

DISEASE CHARACTERISTICS:

Histologically confirmed stage II or IIIa (T1-T3, N1-N2, M0) adenocarcinoma of the breast HER2 overexpression (2-3+ by immunochemistry)
Bilateral breast cancer allowed
Must have had local breast cancer surgery within past 12 weeks
Mastectomy or lumpectomy with clear surgical margins AND axillary lymph node dissection with at least 6 nodes removed
Hormone receptor status: Not specified

PATIENT CHARACTERISTICS:

Age: 18 and over
Sex: Female
WBC at least 3,000/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9 g/dL
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
Creatinine no greater than 1.5 times ULN
LVEF at least 50%
No history of congestive cardiomyopathy
No congestive heart failure or myocardial infarction within the past 6 months
No uncontrolled hypertension
No uncontrolled arrhythmia within the past 6 months
No other prior malignancy within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
No other serious medical illness that would limit survival to less than 2 years
No psychiatric condition precluding study
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

No prior chemotherapy for breast cancer
No prior hormonal therapy for breast cancer
At least one year since prior tamoxifen for chemoprevention (e.g., Breast Cancer Prevention Trial)
No prior radiotherapy to the breast, chest wall, or regional lymph nodes

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)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Arm I Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab (Herceptin) repeats weekly for 10 courses. At 3 weeks following paclitaxel and trastuzumab (Herceptin), patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses. Following chemotherapy, estrogen receptor (ER) positive and/or progesterone receptor (PR) positive patients receive oral tamoxifen twice daily for 5 years.	Medicin: cyclophosphamid Medicin: doxorubicin hydrochlorid Medicin: paclitaxel Biologisk: trastuzumab Medicin: tamoxifen citrat
Eksperimentel: Arm II Patients receive same therapy as in Arm I, except for additional trastuzumab (Herceptin) IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year. ER and/or PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab (Herceptin). Following completion of doxorubicin and cyclophosphamide, post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.	Medicin: cyclophosphamid Medicin: doxorubicin hydrochlorid Medicin: paclitaxel Biologisk: trastuzumab

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Arm I

Patients receive paclitaxel IV over 3 hours immediately followed by trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Paclitaxel repeats every 3 weeks for 4 courses and trastuzumab (Herceptin) repeats weekly for 10 courses. At 3 weeks following paclitaxel and trastuzumab (Herceptin), patients receive doxorubicin IV and cyclophosphamide IV over 1 hour every 3 weeks for 4 courses. Following chemotherapy, estrogen receptor (ER) positive and/or progesterone receptor (PR) positive patients receive oral tamoxifen twice daily for 5 years.

Medicin: cyclophosphamid

Medicin: doxorubicin hydrochlorid

Medicin: paclitaxel

Biologisk: trastuzumab

Medicin: tamoxifen citrat

Eksperimentel: Arm II

Patients receive same therapy as in Arm I, except for additional trastuzumab (Herceptin) IV weekly beginning within 3 weeks following completion of chemotherapy and local therapy and continuing for 1 year. ER and/or PR positive patients receive tamoxifen as in Arm I but may be concurrent with trastuzumab (Herceptin). Following completion of doxorubicin and cyclophosphamide, post lumpectomy and post mastectomy patients may receive local radiotherapy daily for 5-6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Medicin: cyclophosphamid

Medicin: doxorubicin hydrochlorid

Medicin: paclitaxel

Biologisk: trastuzumab

Samarbejdspartnere og efterforskere

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

Sponsor

National Cancer Institute (NCI)

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

Sledge GW, O'Neill A, Thor A, et al.: Adjuvant trastuzumab: long-term results of E2198. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-2075, S106, 2006.

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. august 1999

Primær færdiggørelse (Faktiske)

1. januar 2007

Studieafslutning (Faktiske)

1. marts 2009

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

8. juni 2004

Først opslået (Skøn)

9. juni 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2013

Sidst verificeret

1. marts 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCI-2012-02305
E-2198
CDR0000067197 (Registry Identifier: PDQ (Physician Data Query))

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 .