Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00003855
First received: November 1, 1999
Last updated: July 6, 2015
Last verified: July 2015
  Purpose

RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.

PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.


Condition Intervention Phase
Breast Cancer
Procedure: axillary lymph node dissection
Radiation: whole breast irradiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 605
Study Start Date: April 1999
Study Completion Date: February 2011
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgery + radiotherapy

Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks. Patients may receive adjuvant systemic therapy at the discretion of the treating physician.

Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.

Procedure: axillary lymph node dissection Radiation: whole breast irradiation
Active Comparator: Radiotherapy

Patients undergo breast radiotherapy only. Patients may receive adjuvant systemic therapy at the discretion of the treating physician.

Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.

Radiation: whole breast irradiation

Detailed Description:

OBJECTIVES:

Primary objectives:

Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1 (completion ALND).

Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND versus SLND alone.

OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

PLEASE NOTE: Patients registered to this study may undergo intra-operative or post¬operative randomization.

  1. Patient must be female.
  2. Patient must be at least 18 years of age.
  3. Patient's clinical stage must be documented as tumor size less than 5 cm, with no palpable nodes and no evidence of metastatic disease (T1 or T2 N0 M0; see appendices for staging criteria) and the tumor documented as amenable to lumpectomy.
  4. 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.
  5. Date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of carcinoma must be no more than 60 days prior to the SLND.
  6. The patient who had BCT (segmental mastectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the BCT was less than or equal to 60 days prior to the SLND. NOTE: Copies of the operative and pathology reports must be submitted as part of the registration process.
  7. Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
  8. Patient must be available for follow-up.
  9. Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
  10. Patient must have access to radiation therapy.
  11. A sentinel lymph node must be identified that contains metastatic breast cancer as documented by frozen section, touch prep, or H&E staining on permanent section.

    • NOTE: Patients with metastatic breast cancer identified by immunohistochemistry (IHC) are not eligible.
  12. Patient randomized to ALND must undergo ALND within 42 days of their SLND.
  13. A 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.
  14. Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
  15. Patient must provide written authorization to allow the use and disclosure of their protected health information. NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration.

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 has concurrent invasive bilateral breast malignancies.
  5. Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
  6. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
  7. Patient has a medical contraindication to ALND or is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
  8. Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
  9. Patient has three or more positive sentinel nodes by frozen section, touch prep, or H&E staining on permanent section.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003855

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36640-0460
Providence Cancer Center
Mobile, Alabama, United States, 36608
United States, Arizona
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Arkansas
Washington Regional Medical Center
Fayetteville, Arkansas, United States, 72703
St. Vincent Doctors Doctors Hospital
Little Rock, Arkansas, United States, 72205-5331
Baptist Health Medical Center
Little Rock, Arkansas, United States, 72205-7200
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Mercy San Juan Hospital
Carmichael, California, United States, 95608
Arrowhead Regional Medical Center
Colton, California, United States, 92324-1819
Mount Diablo Regional Cancer Center
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Summit Medical Center
Oakland, California, United States, 94609
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868-3849
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States, 91105
Shasta Regional Medical Center
Redding, California, United States, 96001-0853
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sharp Memorial Hospital
San Diego, California, United States, 92123
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States, 90404
Sonoma Valley Hospital
Sonoma, California, United States, 95476
St. Joseph's Regional Cancer Center
Stockton, California, United States, 95204
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States, 80909
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804-1057
Watson Clinic
Lakeland, Florida, United States, 33805
Martin Memorial Cancer Center
Stuart, Florida, United States, 34995-9010
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Albany, Georgia, United States, 31701
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31702
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Surgical Oncology of Northeast Georgia
Gainesville, Georgia, United States, 30501
United States, Hawaii
Kaiser Permanente Medical Center
Honolulu, Hawaii, United States, 96819
St. Francis Medical Center
Honolulu, Hawaii, United States, 96817
United States, Idaho
St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
United States, Illinois
Belleville Memorial Hospital
Belleville, Illinois, United States, 62226-5399
St. Elizabeth's Hospital
Belleville, Illinois, United States, 62220-1998
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-9985
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
United States, Indiana
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Deaconess Hospital
Evansville, Indiana, United States, 47747
St. Mary's Medical Center
Evansville, Indiana, United States, 47750
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
Norton Healthcare Cancer Center
Louisville, Kentucky, United States, 40202-5070
United States, Louisiana
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States, 70821-2511
Woman's Hospital
Baton Rouge, Louisiana, United States, 70815
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0001
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Great Lakes Cancer Institute - McLaren
Flint, Michigan, United States, 48532
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439-8066
Butterworth Hospital
Grand Rapids, Michigan, United States, 49503
Spectrum Health - Blodgett Campus
Grand Rapids, Michigan, United States, 49506
Spectrum Health Downtown Campus
Grand Rapids, Michigan, United States, 49503
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Minnesota
United Hospital
Saint Paul, Minnesota, United States, 55102
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2576
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
St. Louis University Hospital Cancer Center
Saint Louis, Missouri, United States, 63110-0250
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807-1988
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Southern New Hampshire Medical Center
Nashua, New Hampshire, United States, 03061-2014
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Marlton, New Jersey, United States, 08053
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962-1956
United States, New York
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York, United States, 10466
Lutheran Medical Center
Brooklyn, New York, United States, 11220
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Fern Feldman Anolick Breast Center at Benedictine Hospital
Kingston, New York, United States, 12401
Kingston Hospital
Kingston, New York, United States, 12401-4692
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021-4885
Highland Hospital of Rochester
Rochester, New York, United States, 14620
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28816
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States, 90027
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States, 43210-1240
Good Samaritan Hospital
Dayton, Ohio, United States, 45406-1891
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Middletown Regional Hospital
Middletown, Ohio, United States, 45044-4898
Flower Hospital - ProMedica Health System
Sylvania, Ohio, United States, 43560
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Hospital
Toledo, Ohio, United States, 43606
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oregon
Kaiser Permanente Medical Office - Mother Joseph Plaza
Portland, Oregon, United States, 97225
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Sacred Heart Hospital
Allentown, Pennsylvania, United States, 18102
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105-1556
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Easton Hospital
Easton, Pennsylvania, United States, 18042
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Williamsport Hospital
Williamsport, Pennsylvania, United States, 17701-1995
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, South Dakota
Avera Sacred Heart Hospital
Yankton, South Dakota, United States, 57078
United States, Tennessee
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
Memphis, Tennessee, United States, 38120
Baptist Hospital
Nashville, Tennessee, United States, 37236
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6860
United States, Texas
Seton Shivers Cancer Program at Brackenridge Hospital
Austin, Texas, United States, 78701
Baylor University Medical Center
Dallas, Texas, United States, 75246
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Parkland Health and Hospital System
Dallas, Texas, United States, 75235-7786
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235-7707
St. Paul University Hospital
Dallas, Texas, United States, 75235
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9155
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0542
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78045
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Southwest Cancer and Research Center at University Medical Center
Lubbock, Texas, United States, 79415-3364
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84132
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Carilion New River Valley Medical Center
Christiansburg, Virginia, United States, 24073
INOVA Fair Oaks Hospital
Fairfax, Virginia, United States, 22033
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Carilion Health System - Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24033
United States, Washington
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-7375
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215-5166
Australia, Victoria
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Ireland
Cork University Hospital
Cork, Ireland
St. Vincent's University Hospital
Dublin, Ireland, 4
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Armando E. Giuliano, MD John Wayne Cancer Institute at Saint John's Health Center
  More Information

Additional Information:
Publications:
Leitch AM, McCall L, Beitsch P, et al.: Factors influencing accrual to ACOSOG Z0011, a randomized phase III trial of axillary dissection vs. observation for sentinel node positive breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-601, 2006.

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00003855     History of Changes
Other Study ID Numbers: ACOSOG-Z0011, GUMC-00153, CDR0000067018
Study First Received: November 1, 1999
Last Updated: July 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on July 27, 2015