NCT00003855

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
605

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_3 breast-cancer

Geographic Reach
4 countries

156 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

8.3 years

First QC Date

November 1, 1999

Last Update Submit

April 28, 2020

Conditions

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    Up to 10 years

  • Morbidity

    Up to 10 years

  • Disease-free survival

    Up to 10 years

Study Arms (2)

Surgery + radiotherapy

EXPERIMENTAL

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 dissectionRadiation: whole breast irradiation

Radiotherapy

ACTIVE COMPARATOR

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

Interventions

Surgery + radiotherapy
RadiotherapySurgery + radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PLEASE NOTE: Patients registered to this study may undergo intra-operative or post¬operative randomization.
  • Patient must be female.
  • Patient must be at least 18 years of age.
  • 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.
  • 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.
  • 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.
  • 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.
  • Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
  • Patient must be available for follow-up.
  • Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
  • Patient must have access to radiation therapy.
  • 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.
  • Patient randomized to ALND must undergo ALND within 42 days of their SLND.
  • 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:
  • +5 more criteria

You may not qualify if:

  • Patient is lactating (breastfeeding).
  • 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.
  • Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
  • Patient has concurrent invasive bilateral breast malignancies.
  • Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
  • Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
  • 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.
  • Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
  • Patient has three or more positive sentinel nodes by frozen section, touch prep, or H\&E staining on permanent section.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (156)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Providence Cancer Center

Mobile, Alabama, 36608, United States

Location

Mobile Infirmary Medical Center

Mobile, Alabama, 36640-0460, United States

Location

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

St. Vincent Doctors Doctors Hospital

Little Rock, Arkansas, 72205-5331, United States

Location

Baptist Health Medical Center

Little Rock, Arkansas, 72205-7200, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Mercy San Juan Hospital

Carmichael, California, 95608, United States

Location

Arrowhead Regional Medical Center

Colton, California, 92324-1819, United States

Location

Mount Diablo Regional Cancer Center

Concord, California, 94524-4110, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Summit Medical Center

Oakland, California, 94609, United States

Location

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, 92868-3849, United States

Location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Huntington Cancer Center at Huntington Hospital

Pasadena, California, 91105, United States

Location

Shasta Regional Medical Center

Redding, California, 96001-0853, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, 90404, United States

Location

Sonoma Valley Hospital

Sonoma, California, 95476, United States

Location

St. Joseph's Regional Cancer Center

Stockton, California, 95204, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Memorial Hospital Cancer Center

Colorado Springs, Colorado, 80909, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Lombardi Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, 33804-1057, United States

Location

Watson Clinic

Lakeland, Florida, 33805, United States

Location

Martin Memorial Cancer Center

Stuart, Florida, 34995-9010, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Unknown Facility

Albany, Georgia, 31701, United States

Location

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

Albany, Georgia, 31702, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Surgical Oncology of Northeast Georgia

Gainesville, Georgia, 30501, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kaiser Permanente Medical Center

Honolulu, Hawaii, 96819, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

St. Elizabeth's Hospital

Belleville, Illinois, 62220-1998, United States

Location

Belleville Memorial Hospital

Belleville, Illinois, 62226-5399, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612-9985, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Deaconess Hospital

Evansville, Indiana, 47747, United States

Location

St. Mary's Medical Center

Evansville, Indiana, 47750, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503-9985, United States

Location

Norton Healthcare Cancer Center

Louisville, Kentucky, 40202-5070, United States

Location

Woman's Hospital

Baton Rouge, Louisiana, 70815, United States

Location

Baton Rouge General Regional Cancer Center

Baton Rouge, Louisiana, 70821-2511, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Fallon Clinic at Worcester Medical Center

Worcester, Massachusetts, 01608, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0001, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Great Lakes Cancer Institute - McLaren

Flint, Michigan, 48532, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439-8066, United States

Location

Butterworth Hospital

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Downtown Campus

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health - Blodgett Campus

Grand Rapids, Michigan, 49506, United States

Location

Henry Ford Medical Center - West Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

Park Nicollet Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807-1988, United States

Location

St. Louis University Hospital Cancer Center

St Louis, Missouri, 63110-0250, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Southern New Hampshire Medical Center

Nashua, New Hampshire, 03061-2014, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

Marlton, New Jersey, 08053, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962-1956, United States

Location

Lutheran Medical Center

Brooklyn, New York, 11220, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

Cooperstown, New York, 13326, United States

Location

Kingston Hospital

Kingston, New York, 12401-4692, United States

Location

Fern Feldman Anolick Breast Center at Benedictine Hospital

Kingston, New York, 12401, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021-4885, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Comprehensive Cancer Center at Our Lady of Mercy Medical Center

The Bronx, New York, 10466, United States

Location

Hope A Women's Cancer Center

Asheville, North Carolina, 28816, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Tri-Health Good Samaritan Hospital

Cincinnati, Ohio, 90027, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5065, United States

Location

Arthur G. James Cancer Hospital at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406-1891, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044-4898, United States

Location

Flower Hospital - ProMedica Health System

Sylvania, Ohio, 43560, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

Kaiser Permanente Medical Office - Mother Joseph Plaza

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Sacred Heart Hospital

Allentown, Pennsylvania, 18102, United States

Location

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, 18105-1556, United States

Location

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, 18015, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Easton Hospital

Easton, Pennsylvania, 18042, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States

Location

Williamsport Hospital

Williamsport, Pennsylvania, 17701-1995, United States

Location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Avera Sacred Heart Hospital

Yankton, South Dakota, 57078, United States

Location

Baptist Cancer Institute at Baptist Memorial Hospital - Memphis

Memphis, Tennessee, 38120, United States

Location

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6860, United States

Location

Baptist Hospital

Nashville, Tennessee, 37236, United States

Location

Seton Shivers Cancer Program at Brackenridge Hospital

Austin, Texas, 78701, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Zale Lipshy University Hospital

Dallas, Texas, 75235-7707, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75235-7786, United States

Location

St. Paul University Hospital

Dallas, Texas, 75235, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9155, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0542, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Baylor University Medical Center - Houston

Houston, Texas, 77030, United States

Location

Doctor's Hospital of Laredo

Laredo, Texas, 78045, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410-1894, United States

Location

Southwest Cancer and Research Center at University Medical Center

Lubbock, Texas, 79415-3364, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84770, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Carilion New River Valley Medical Center

Christiansburg, Virginia, 24073, United States

Location

INOVA Fair Oaks Hospital

Fairfax, Virginia, 22033, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042-3300, United States

Location

Carilion Health System - Cancer Center of Western Virginia

Roanoke, Virginia, 24033, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

West Virginia University Hospitals

Morgantown, West Virginia, 26506-9300, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-7375, United States

Location

Vince Lombardi Cancer Clinic at St. Luke's Medical Center

Milwaukee, Wisconsin, 53215-5166, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Peter MacCallum Cancer Centre

East Melbourne, Victoria, 3002, Australia

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Cork University Hospital

Cork, Ireland

Location

St. Vincent's University Hospital

Dublin, 4, Ireland

Location

Related Publications (11)

  • 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.

    PMID: 23290275BACKGROUND
  • 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.

    PMID: 22820938BACKGROUND
  • 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.

    PMID: 18640934BACKGROUND
  • 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.

    BACKGROUND
  • 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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Armando E. Giuliano, MD

    Saint John's Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1999

Primary Completion

August 1, 2007

Study Completion

February 1, 2011

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations