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

July 12, 2016 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

4590

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: therapeutic conventional surgery
Other: immunohistochemistry staining method
Procedure: lymphangiography
Procedure: sentinel lymph node biopsy
Radiation: whole breast irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 10 years
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: Up to 10 years
Up to 10 years
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 13, 2016

Last Update Submitted That Met QC Criteria

July 12, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOSOG-Z0010
  • GUMC-00152
  • CDR0000067017 (Registry Identifier: NCI Physician Data Query)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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