Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer
NCT ID: NCT00003855
Last Updated: 2020-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
605 participants
INTERVENTIONAL
1999-04-30
2011-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
axillary lymph node dissection
whole breast irradiation
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.
whole breast irradiation
Interventions
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axillary lymph node dissection
whole breast irradiation
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Armando E. Giuliano, MD
Role: STUDY_CHAIR
Saint John's Cancer Institute
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Providence Cancer Center
Mobile, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
St. Vincent Doctors Doctors Hospital
Little Rock, Arkansas, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Mercy San Juan Hospital
Carmichael, California, United States
Arrowhead Regional Medical Center
Colton, California, United States
Mount Diablo Regional Cancer Center
Concord, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Summit Medical Center
Oakland, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
Huntington Cancer Center at Huntington Hospital
Pasadena, California, United States
Shasta Regional Medical Center
Redding, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
John Wayne Cancer Institute at Saint John's Health Center
Santa Monica, California, United States
Sonoma Valley Hospital
Sonoma, California, United States
St. Joseph's Regional Cancer Center
Stockton, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
Watson Clinic
Lakeland, Florida, United States
Martin Memorial Cancer Center
Stuart, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Albany, Georgia, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States
Surgical Oncology of Northeast Georgia
Gainesville, Georgia, United States
St. Francis Medical Center
Honolulu, Hawaii, United States
Kaiser Permanente Medical Center
Honolulu, Hawaii, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
St. Elizabeth's Hospital
Belleville, Illinois, United States
Belleville Memorial Hospital
Belleville, Illinois, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Deaconess Hospital
Evansville, Indiana, United States
St. Mary's Medical Center
Evansville, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Norton Healthcare Cancer Center
Louisville, Kentucky, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Baton Rouge General Regional Cancer Center
Baton Rouge, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
Great Lakes Cancer Institute - McLaren
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Butterworth Hospital
Grand Rapids, Michigan, United States
Spectrum Health Downtown Campus
Grand Rapids, Michigan, United States
Spectrum Health - Blodgett Campus
Grand Rapids, Michigan, United States
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Southern New Hampshire Medical Center
Nashua, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Marlton, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Lutheran Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
Cooperstown, New York, United States
Kingston Hospital
Kingston, New York, United States
Fern Feldman Anolick Breast Center at Benedictine Hospital
Kingston, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
The Bronx, New York, United States
Hope A Women's Cancer Center
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital at Ohio State University
Columbus, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Middletown Regional Hospital
Middletown, Ohio, United States
Flower Hospital - ProMedica Health System
Sylvania, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Kaiser Permanente Medical Office - Mother Joseph Plaza
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Sacred Heart Hospital
Allentown, Pennsylvania, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Easton Hospital
Easton, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Williamsport Hospital
Williamsport, Pennsylvania, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Avera Sacred Heart Hospital
Yankton, South Dakota, United States
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
Memphis, Tennessee, United States
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States
Baptist Hospital
Nashville, Tennessee, United States
Seton Shivers Cancer Program at Brackenridge Hospital
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Zale Lipshy University Hospital
Dallas, Texas, United States
Parkland Health and Hospital System
Dallas, Texas, United States
St. Paul University Hospital
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Southwest Cancer and Research Center at University Medical Center
Lubbock, Texas, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Carilion New River Valley Medical Center
Christiansburg, Virginia, United States
INOVA Fair Oaks Hospital
Fairfax, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Health System - Cancer Center of Western Virginia
Roanoke, Virginia, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Cork University Hospital
Cork, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Countries
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References
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Ainsworth RK, Kollias J, Le Blanc A, De Silva P. The clinical impact of the American College of Surgeons Oncology Group Z-0011 trial--results from the BreastSurgANZ National Breast Cancer Audit. Breast. 2013 Oct;22(5):733-5. doi: 10.1016/j.breast.2012.11.005. Epub 2013 Jan 2.
Gainer SM, Hunt KK, Beitsch P, Caudle AS, Mittendorf EA, Lucci A. Changing behavior in clinical practice in response to the ACOSOG Z0011 trial: a survey of the American Society of Breast Surgeons. Ann Surg Oncol. 2012 Oct;19(10):3152-8. doi: 10.1245/s10434-012-2523-z. Epub 2012 Jul 21.
Olson JA Jr, McCall LM, Beitsch P, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group Trials Z0010 and Z0011. Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011. J Clin Oncol. 2008 Jul 20;26(21):3530-5. doi: 10.1200/JCO.2007.15.5630.
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.
Krishnan MS, Recht A, Bellon JR, Punglia RS. Trade-offs associated with axillary lymph node dissection with breast irradiation versus breast irradiation alone in patients with a positive sentinel node in relation to the risk of non-sentinel node involvement: implications of ACOSOG Z0011. Breast Cancer Res Treat. 2013 Feb;138(1):205-13. doi: 10.1007/s10549-013-2418-0. Epub 2013 Jan 22.
Shah-Khan M, Boughey JC. Evolution of axillary nodal staging in breast cancer: clinical implications of the ACOSOG Z0011 trial. Cancer Control. 2012 Oct;19(4):267-76. doi: 10.1177/107327481201900403.
Caudle AS, Hunt KK, Kuerer HM, Meric-Bernstam F, Lucci A, Bedrosian I, Babiera GV, Hwang RF, Ross MI, Feig BW, Hoffman K, Litton JK, Sahin AA, Yang W, Hortobagyi GN, Buchholz TA, Mittendorf EA. Multidisciplinary considerations in the implementation of the findings from the American College of Surgeons Oncology Group (ACOSOG) Z0011 study: a practice-changing trial. Ann Surg Oncol. 2011 Sep;18(9):2407-12. doi: 10.1245/s10434-011-1593-7. No abstract available.
Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.
Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM, Saha S, Hunt KK, Morrow M, Ballman K. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg. 2010 Sep;252(3):426-32; discussion 432-3. doi: 10.1097/SLA.0b013e3181f08f32.
Lucci A, McCall LM, Beitsch PD, Whitworth PW, Reintgen DS, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Giuliano AE; American College of Surgeons Oncology Group. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol. 2007 Aug 20;25(24):3657-63. doi: 10.1200/JCO.2006.07.4062. Epub 2007 May 7.
Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.
Related Links
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Other Identifiers
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GUMC-00153
Identifier Type: -
Identifier Source: secondary_id
CDR0000067018
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0011
Identifier Type: -
Identifier Source: org_study_id
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