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Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

12 luglio 2016 aggiornato da: Alliance for Clinical Trials in Oncology

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer.

PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

  • Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer.
  • Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.
  • Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.
  • Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

4590

Fase

  • Fase 3

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

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 8006
        • Peter Maccallum Cancer Institute
  • Irlanda
      • Cork, Irlanda
        • Cork University Hospital
      • Dublin, Irlanda, 4
        • St. Vincent'S University Hospital
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
      • Mobile, Alabama, Stati Uniti, 36640-0460
        • Mobile Infirmary Medical Center
      • Mobile, Alabama, Stati Uniti, 36685
        • Providence Hospital - Mobile AL
    • Arizona
      • Scottsdale, Arizona, Stati Uniti, 85259
        • Mayo Clinic Scottsdale
    • Arkansas
      • Fayetteville, Arkansas, Stati Uniti, 72703
        • Washington Regional Medical Center
      • Little Rock, Arkansas, Stati Uniti, 72205-5331
        • St. Vincent Doctors Doctors Hospital
      • Little Rock, Arkansas, Stati Uniti, 72205-7200
        • Baptist Health Medical Center
    • California
      • Los Angeles, California, Stati Uniti, 90027
        • Kaiser Permanente Medical Center - Los Angeles
      • Oakland, California, Stati Uniti, 94609
        • Summit Medical Center
      • Orange, California, Stati Uniti, 92868-3849
        • St. Joseph Hospital - Orange
      • Pasadena, California, Stati Uniti, 91109-7013
        • Huntington Memorial Hospital
      • Sacramento, California, Stati Uniti, 95817
        • University of California Davis Cancer Center
      • San Diego, California, Stati Uniti, 92123
        • Donald N. Sharp Memorial Community Hospital
      • San Francisco, California, Stati Uniti, 94143-0128
        • UCSF Comprehensive Cancer Center
      • Santa Monica, California, Stati Uniti, 90404
        • John Wayne Cancer Institute
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80909
        • Memorial Hospital Cancer Center
      • Denver, Colorado, Stati Uniti, 80010
        • University of Colorado Cancer Center
    • Connecticut
      • Farmington, Connecticut, Stati Uniti, 06030-3955
        • University of Connecticut Health Center
    • Delaware
      • Wilmington, Delaware, Stati Uniti, 19899
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Lombardi Cancer Center
    • Florida
      • Clearwater, Florida, Stati Uniti, 33756
        • Morton Plant Mease Health Care
      • Lakeland, Florida, Stati Uniti, 33804
        • Lakeland Regional Medical Center
      • Lakeland, Florida, Stati Uniti, 33805
        • Watson Clinic
      • Saint Petersburg, Florida, Stati Uniti, 33701
        • Bayfront Medical Center
      • Stuart, Florida, Stati Uniti, 34995
        • Martin Memorial Cancer Medical Center
      • Tallahassee, Florida, Stati Uniti, 32308
        • Tallahassee Memorial HealthCare
      • Tampa, Florida, Stati Uniti, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Decatur, Georgia, Stati Uniti, 30033
        • DeKalb Medical Center, Inc.
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96819
        • Kaiser Permanente Medical Center
      • Honolulu, Hawaii, Stati Uniti, 96817
        • St. Francis Medical Center
    • Idaho
      • Boise, Idaho, Stati Uniti, 83712
        • St. Luke's Regional Medical Center
    • Illinois
      • Belleville, Illinois, Stati Uniti, 62220-1998
        • St. Elizabeth's Hospital
      • Belleville, Illinois, Stati Uniti, 62226-5399
        • Belleville Memorial Hospital
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University Medical Center
      • Evanston, Illinois, Stati Uniti, 60201
        • Evanston Northwestern Health Care
      • Evanston, Illinois, Stati Uniti, 60201
        • CCOP - Evanston
      • Evergreen Park, Illinois, Stati Uniti, 60805-2746
        • Little Company of Mary Hospital - Evergreen Park
      • Maywood, Illinois, Stati Uniti, 60153
        • Loyola University Medical Center
    • Indiana
      • Michigan City, Indiana, Stati Uniti, 46360
        • Saint Anthony Memorial Health Center - Michigan City Campus
    • Kansas
      • Kansas City, Kansas, Stati Uniti, 66160-7357
        • University of Kansas Medical Center
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40503-9985
        • Central Baptist Hospital
      • Louisville, Kentucky, Stati Uniti, 40202
        • James Graham Brown Cancer Center
      • Louisville, Kentucky, Stati Uniti, 40202-5070
        • Norton Healthcare System
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70821-2511
        • Baton Rouge General Medical Center
      • Baton Rouge, Louisiana, Stati Uniti, 70815
        • Woman's Hospital
    • Maryland
      • Annapolis, Maryland, Stati Uniti, 21401
        • Anne Arundel Medical Center
    • Massachusetts
      • Burlington, Massachusetts, Stati Uniti, 01805
        • Lahey Clinic - Burlington
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Stati Uniti, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Flint, Michigan, Stati Uniti, 48432
        • McLaren Regional Cancer Center
      • Grand Blanc, Michigan, Stati Uniti, 48439-8066
        • Genesys Regional Medical Center
      • Grand Rapids, Michigan, Stati Uniti, 49546
        • Spectrum Health - Butterworth Campus
      • West Bloomfield, Michigan, Stati Uniti, 48322
        • Henry Ford Medical Center - West Bloomfield
    • Minnesota
      • St. Louis Park, Minnesota, Stati Uniti, 55416
        • Park Nicollet Clinic
    • Mississippi
      • Keesler AFB, Mississippi, Stati Uniti, 39534-2576
        • Keesler Medical Center - Keesler AFB
      • Pascagoula, Mississippi, Stati Uniti, 39581
        • Singing River Hospital
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65212
        • University of Missouri-Columbia Hospital and Clinics
      • Columbia, Missouri, Stati Uniti, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Columbia, Missouri, Stati Uniti, 65201
        • Columbia Regional Hospital
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, Stati Uniti, 63110-2500
        • St. Louis University Health Sciences Center
      • Springfield, Missouri, Stati Uniti, 65807-1988
        • Lester E. Cox Medical Centers
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center
    • New Jersey
      • Mount Holly, New Jersey, Stati Uniti, 08060
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
    • New York
      • Brooklyn, New York, Stati Uniti, 11220
        • Lutheran Medical Center
      • Buffalo, New York, Stati Uniti, 14263-0001
        • Roswell Park Cancer Institute
      • Kingston, New York, Stati Uniti, 12401
        • Benedictine Hospital
      • Kingston, New York, Stati Uniti, 12401-4692
        • Kingston Hospital
      • New York, New York, Stati Uniti, 10021
        • New York Presbyterian Hospital - Cornell Campus
      • New York, New York, Stati Uniti, 10019
        • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester Medical Center
      • Rochester, New York, Stati Uniti, 14620
        • Highland Hospital of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7295
        • Lineberger Comprehensive Cancer Center, UNC
      • Charlotte, North Carolina, Stati Uniti, 28232-2861
        • Carolinas Medical Center
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke Comprehensive Cancer Center
      • Durham, North Carolina, Stati Uniti, 27704-2763
        • Durham Regional Hospital
      • Fayetteville, North Carolina, Stati Uniti, 28302-2000
        • Cape Fear Valley Health System
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 90027
        • Tri-Health Good Samaritan Hospital
      • Cleveland, Ohio, Stati Uniti, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, Stati Uniti, 43210-1228
        • Arthur G. James Cancer Hospital - Ohio State University
      • Toledo, Ohio, Stati Uniti, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Stati Uniti, 43606
        • Toledo Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti, 18102
        • Sacred Heart Hospital
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Fox Chase Cancer Center
      • Pittsburgh, Pennsylvania, Stati Uniti, 15219
        • Mercy Hospital of Pittsburgh
      • York, Pennsylvania, Stati Uniti, 17403
        • York Cancer Center
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02905
        • Women and Infants Hospital of Rhode Island
      • Warwick, Rhode Island, Stati Uniti, 02886
        • Kent County Memorial Hospital
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Stati Uniti, 37203
        • Sarah Cannon-Minnie Pearl Cancer Center
      • Nashville, Tennessee, Stati Uniti, 37236
        • Baptist Hospital
    • Texas
      • Austin, Texas, Stati Uniti, 78701
        • Texas Cancer Center at Brackenridge Hospital
      • Dallas, Texas, Stati Uniti, 75235-9154
        • Simmons Cancer Center - Dallas
      • Dallas, Texas, Stati Uniti, 75246
        • Baylor University Medical Center
      • Dallas, Texas, Stati Uniti, 75235
        • St. Paul University Hospital
      • Dallas, Texas, Stati Uniti, 75235-7786
        • Zale Lipshy University Hospital
      • Galveston, Texas, Stati Uniti, 77555-0542
        • University of Texas Medical Branch
      • Houston, Texas, Stati Uniti, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Houston, Texas, Stati Uniti, 77030
        • Ben Taub General Hospital
      • Houston, Texas, Stati Uniti, 77030
        • Methodist Hospital
      • Lubbock, Texas, Stati Uniti, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84132
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, Stati Uniti, 84143
        • Latter Day Saints Hospital
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • Cancer Center at the University of Virginia
      • Christiansburg, Virginia, Stati Uniti, 24073
        • Carilion New River Valley Medical Center
      • Falls Church, Virginia, Stati Uniti, 22042-3300
        • Inova Fairfax Hospital
      • Roanoke, Virginia, Stati Uniti, 24033
        • Carilion Health System - Cancer Center of Western Virginia
      • Salem, Virginia, Stati Uniti, 24153
        • Columbia Lewis-Gale Medical Center
    • Washington
      • Seattle, Washington, Stati Uniti, 98195-6043
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, Stati Uniti, 53201-0342
        • Aurora Sinai Medical Center
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Froedtert Memorial Lutheran Hospital
      • Milwaukee, Wisconsin, Stati Uniti, 53215-5166
        • St. Luke's Medical Center

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

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  1. Patient must be female.
  2. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (lumpectomy).
  3. Patient must have a tissue diagnosis of invasive breast carcinoma. Note: A patient can be registered to this study if they have a cytologic diagnosis suggestive of carcinoma from a fine needle aspiration (FNA) of a palpable or non-palpable breast lesion and the investigator believes the breast lesion is clinically suspicious for invasive breast carcinoma.
  4. The date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.
  5. The patient who had segmental mastectomy (lumpectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the lumpectomy was less than or equal to 60 days prior to the SLND. Copies of the operative and pathology reports must be submitted as a part of the registration process.
  6. Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record.
  7. Patient must be available for follow-up.

  8. The patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided that the following criteria are met:

    1. The patient has undergone potentially curative therapy for all prior malignancies.
    2. There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone), and
    3. The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
  9. Signed and dated informed consent is obtained prior to patient registration.
  10. Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
  11. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration.

Exclusion Criteria:

  1. Patient is lactating (breastfeeding).
  2. Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e. Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e. Raloxifene) for this invasive breast cancer.
  3. Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
  4. Patient is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options.
  5. Patient has concurrent bilateral invasive breast malignancies.

  6. Patient is not able to undergo and does not have access to radiation therapy as describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.

    Patients with active connective tissue disorders and those that live too far from a radiation treatment center, for example, would not be eligible.

  7. Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
  8. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.

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: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Surgery + radiotherapy + adjuvant therapy

Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology.

Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes.

All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks.

Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually until 10 years after surgery.
Procedura: chirurgia convenzionale terapeutica
Altro: metodo di colorazione immunoistochimica
Procedura: linfangiografia
Procedura: biopsia del linfonodo sentinella
Radiazione: irradiazione dell'intero seno

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Sopravvivenza globale
Lasso di tempo: Fino a 10 anni
Fino a 10 anni

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Sopravvivenza libera da malattia
Lasso di tempo: Fino a 10 anni
Fino a 10 anni
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND
Lasso di tempo: Up to 10 years
Up to 10 years

Collaboratori e investigatori

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Armando E. Giuliano, MD, Saint John's Cancer Institute

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

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 aprile 1999

Completamento primario (Effettivo)

1 agosto 2006

Completamento dello studio (Effettivo)

1 luglio 2011

Date di iscrizione allo studio

Primo inviato

1 novembre 1999

Primo inviato che soddisfa i criteri di controllo qualità

26 gennaio 2003

Primo Inserito (Stima)

27 gennaio 2003

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 luglio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACOSOG-Z0010
  • GUMC-00152
  • CDR0000067017 (Identificatore di registro: NCI 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 .

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