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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

axillary lymph node dissection

Intervention Type PROCEDURE

whole breast irradiation

Intervention Type RADIATION

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.

Group Type ACTIVE_COMPARATOR

whole breast irradiation

Intervention Type RADIATION

Interventions

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axillary lymph node dissection

Intervention Type PROCEDURE

whole breast irradiation

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Providence Cancer Center

Mobile, Alabama, United States

Site Status

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

CCOP - Mayo Clinic Scottsdale Oncology Program

Scottsdale, Arizona, United States

Site Status

Washington Regional Medical Center

Fayetteville, Arkansas, United States

Site Status

St. Vincent Doctors Doctors Hospital

Little Rock, Arkansas, United States

Site Status

Baptist Health Medical Center

Little Rock, Arkansas, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Mercy San Juan Hospital

Carmichael, California, United States

Site Status

Arrowhead Regional Medical Center

Colton, California, United States

Site Status

Mount Diablo Regional Cancer Center

Concord, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Summit Medical Center

Oakland, California, United States

Site Status

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Site Status

Palo Alto Medical Foundation

Palo Alto, California, United States

Site Status

Huntington Cancer Center at Huntington Hospital

Pasadena, California, United States

Site Status

Shasta Regional Medical Center

Redding, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

UCSF Comprehensive Cancer Center

San Francisco, California, United States

Site Status

John Wayne Cancer Institute at Saint John's Health Center

Santa Monica, California, United States

Site Status

Sonoma Valley Hospital

Sonoma, California, United States

Site Status

St. Joseph's Regional Cancer Center

Stockton, California, United States

Site Status

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

Aurora, Colorado, United States

Site Status

Memorial Hospital Cancer Center

Colorado Springs, Colorado, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Lombardi Cancer Center at Georgetown University Medical Center

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

Site Status

Morton Plant Hospital

Clearwater, Florida, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Watson Clinic

Lakeland, Florida, United States

Site Status

Martin Memorial Cancer Center

Stuart, Florida, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Albany, Georgia, United States

Site Status

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Surgical Oncology of Northeast Georgia

Gainesville, Georgia, United States

Site Status

St. Francis Medical Center

Honolulu, Hawaii, United States

Site Status

Kaiser Permanente Medical Center

Honolulu, Hawaii, United States

Site Status

St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status

St. Elizabeth's Hospital

Belleville, Illinois, United States

Site Status

Belleville Memorial Hospital

Belleville, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Site Status

Evanston Northwestern Health Care - Evanston Hospital

Evanston, Illinois, United States

Site Status

St. Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Site Status

Deaconess Hospital

Evansville, Indiana, United States

Site Status

St. Mary's Medical Center

Evansville, Indiana, United States

Site Status

Central Baptist Hospital

Lexington, Kentucky, United States

Site Status

Norton Healthcare Cancer Center

Louisville, Kentucky, United States

Site Status

Woman's Hospital

Baton Rouge, Louisiana, United States

Site Status

Baton Rouge General Regional Cancer Center

Baton Rouge, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

DeCesaris Cancer Institute at Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Baltimore, Maryland, United States

Site Status

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Site Status

Fallon Clinic at Worcester Medical Center

Worcester, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, United States

Site Status

Great Lakes Cancer Institute - McLaren

Flint, Michigan, United States

Site Status

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Site Status

Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status

Spectrum Health Downtown Campus

Grand Rapids, Michigan, United States

Site Status

Spectrum Health - Blodgett Campus

Grand Rapids, Michigan, United States

Site Status

Henry Ford Medical Center - West Bloomfield

West Bloomfield, Michigan, United States

Site Status

Park Nicollet Clinic

Saint Louis Park, Minnesota, United States

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United Hospital

Saint Paul, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, United States

Site Status

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Site Status

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, United States

Site Status

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Site Status

St. Louis University Hospital Cancer Center

St Louis, Missouri, United States

Site Status

Siteman Cancer Center at Barnes-Jewish Hospital

St Louis, Missouri, United States

Site Status

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Southern New Hampshire Medical Center

Nashua, New Hampshire, United States

Site Status

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

Marlton, New Jersey, United States

Site Status

Morristown Memorial Hospital

Morristown, New Jersey, United States

Site Status

Lutheran Medical Center

Brooklyn, New York, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital

Cooperstown, New York, United States

Site Status

Kingston Hospital

Kingston, New York, United States

Site Status

Fern Feldman Anolick Breast Center at Benedictine Hospital

Kingston, New York, United States

Site Status

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

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Highland Hospital of Rochester

Rochester, New York, United States

Site Status

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

Rochester, New York, United States

Site Status

Comprehensive Cancer Center at Our Lady of Mercy Medical Center

The Bronx, New York, United States

Site Status

Hope A Women's Cancer Center

Asheville, North Carolina, United States

Site Status

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Tri-Health Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

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

Cleveland, Ohio, United States

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Arthur G. James Cancer Hospital at Ohio State University

Columbus, Ohio, United States

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Good Samaritan Hospital

Dayton, Ohio, United States

Site Status

Miami Valley Hospital

Dayton, Ohio, United States

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Middletown Regional Hospital

Middletown, Ohio, United States

Site Status

Flower Hospital - ProMedica Health System

Sylvania, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Greene Memorial Hospital

Xenia, Ohio, United States

Site Status

Kaiser Permanente Medical Office - Mother Joseph Plaza

Portland, Oregon, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Sacred Heart Hospital

Allentown, Pennsylvania, United States

Site Status

John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

St. Luke's Hospital Cancer Center

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Easton Hospital

Easton, Pennsylvania, United States

Site Status

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Mercy Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Mount Nittany Medical Center

State College, Pennsylvania, United States

Site Status

Williamsport Hospital

Williamsport, Pennsylvania, United States

Site Status

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

Avera Sacred Heart Hospital

Yankton, South Dakota, United States

Site Status

Baptist Cancer Institute at Baptist Memorial Hospital - Memphis

Memphis, Tennessee, United States

Site Status

Sarah Cannon Cancer Center at Centennial Medical Center

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, United States

Site Status

Baptist Hospital

Nashville, Tennessee, United States

Site Status

Seton Shivers Cancer Program at Brackenridge Hospital

Austin, Texas, United States

Site Status

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status

Zale Lipshy University Hospital

Dallas, Texas, United States

Site Status

Parkland Health and Hospital System

Dallas, Texas, United States

Site Status

St. Paul University Hospital

Dallas, Texas, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

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

Dallas, Texas, United States

Site Status

University of Texas Medical Branch

Galveston, Texas, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Baylor University Medical Center - Houston

Houston, Texas, United States

Site Status

Doctor's Hospital of Laredo

Laredo, Texas, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Southwest Cancer and Research Center at University Medical Center

Lubbock, Texas, United States

Site Status

Cottonwood Hospital Medical Center

Murray, Utah, United States

Site Status

McKay-Dee Hospital Center

Ogden, Utah, United States

Site Status

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Site Status

Dixie Regional Medical Center

St. George, Utah, United States

Site Status

Cancer Center at the University of Virginia

Charlottesville, Virginia, United States

Site Status

Carilion New River Valley Medical Center

Christiansburg, Virginia, United States

Site Status

INOVA Fair Oaks Hospital

Fairfax, Virginia, United States

Site Status

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status

Carilion Health System - Cancer Center of Western Virginia

Roanoke, Virginia, United States

Site Status

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Site Status

West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

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

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Peter MacCallum Cancer Centre

East Melbourne, Victoria, Australia

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Cork University Hospital

Cork, , Ireland

Site Status

St. Vincent's University Hospital

Dublin, , Ireland

Site Status

Countries

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United States Australia Canada Ireland

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.

Reference Type BACKGROUND
PMID: 23290275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22820938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18640934 (View on PubMed)

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.

Reference Type 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.

Reference Type RESULT
PMID: 23338762 (View on PubMed)

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.

Reference Type RESULT
PMID: 23037494 (View on PubMed)

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.

Reference Type RESULT
PMID: 21327455 (View on PubMed)

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.

Reference Type RESULT
PMID: 21304082 (View on PubMed)

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.

Reference Type RESULT
PMID: 20739842 (View on PubMed)

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.

Reference Type RESULT
PMID: 17485711 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28898379 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://nctn-data-archive.nci.nih.gov/

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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