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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. juli 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

4590

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: terapeutisk konventionel kirurgi
Andet: immunhistokemi farvningsmetode
Procedure: lymfangiografi
Procedure: sentinel lymfeknudebiopsi
Stråling: bestråling af hele brystet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: Op til 10 år
Op til 10 år

Sekundære resultatmål

Resultatmål
Tidsramme
Sygdomsfri overlevelse
Tidsramme: Op til 10 år
Op til 10 år
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND
Tidsramme: Up to 10 years
Up to 10 years

Samarbejdspartnere og efterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Armando E. Giuliano, MD, Saint John's Cancer Institute

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. april 1999

Primær færdiggørelse (Faktiske)

1. august 2006

Studieafslutning (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. juli 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACOSOG-Z0010
  • GUMC-00152
  • CDR0000067017 (Registry Identifier: NCI 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 .

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