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

A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: axillary lymph node dissection; 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.

• Study Type: Interventional
• Enrollment (Actual): 605
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	Up to 10 years
Morbidity	Up to 10 years
Disease-free survival	Up to 10 years

Collaborators and Investigators

• 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

General Publications

• 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.

Helpful Links

• Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): February 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 (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: stage II breast cancer; stage IA breast cancer; stage IB breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ACOSOG-Z0011; GUMC-00153; CDR0000067018 (Registry Identifier: NCI Physician Data Query)