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

31 maggio 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Cancro al seno

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

200

Fase

Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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.	Droga: ciclofosfamide Droga: doxorubicina cloridrato Droga: paclitaxel Biologico: trastuzumab Droga: tamoxifene citrato
Sperimentale: 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.	Droga: ciclofosfamide Droga: doxorubicina cloridrato Droga: paclitaxel Biologico: trastuzumab

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: 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.

Droga: ciclofosfamide

Droga: doxorubicina cloridrato

Droga: paclitaxel

Biologico: trastuzumab

Droga: tamoxifene citrato

Sperimentale: 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.

Droga: ciclofosfamide

Droga: doxorubicina cloridrato

Droga: paclitaxel

Biologico: trastuzumab

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 1999

Completamento primario (Effettivo)

1 gennaio 2007

Completamento dello studio (Effettivo)

1 marzo 2009

Date di iscrizione allo studio

Primo inviato

1 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2004

Primo Inserito (Stima)

9 giugno 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 giugno 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 maggio 2013

Ultimo verificato

1 marzo 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NCI-2012-02305
E-2198
CDR0000067197 (Identificatore di registro: PDQ (Physician Data Query))

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .