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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003855
• Other study ID #: ACOSOG-Z0011
• Secondary ID: GUMC-00153CDR000
• Status: Completed
• Phase: Phase 3
• Start date: April 1999
• Est. completion date: February 2011

Study information

• Verified date: April 2020
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: February 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• axillary lymph node dissection

Radiation:
• whole breast irradiation

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Ireland	Cork University Hospital	Cork
Ireland	St. Vincent's University Hospital	Dublin
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Phoebe Cancer Center at Phoebe Putney Memorial Hospital	Albany	Georgia
United States	John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Sacred Heart Hospital	Allentown	Pennsylvania
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	DeCesaris Cancer Institute at Anne Arundel Medical Center	Annapolis	Maryland
United States	Hope A Women's Cancer Center	Asheville	North Carolina
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Seton Shivers Cancer Program at Brackenridge Hospital	Austin	Texas
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	Baton Rouge General Regional Cancer Center	Baton Rouge	Louisiana
United States	Woman's Hospital	Baton Rouge	Louisiana
United States	St. Francis Hospital and Health Centers	Beech Grove	Indiana
United States	Belleville Memorial Hospital	Belleville	Illinois
United States	St. Elizabeth's Hospital	Belleville	Illinois
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	St. Luke's Regional Medical Center	Boise	Idaho
United States	Comprehensive Cancer Center at Our Lady of Mercy Medical Center	Bronx	New York
United States	Lutheran Medical Center	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Mercy San Juan Hospital	Carmichael	California
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	Carilion New River Valley Medical Center	Christiansburg	Virginia
United States	Tri-Health Good Samaritan Hospital	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University	Cleveland	Ohio
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Arrowhead Regional Medical Center	Colton	California
United States	Ellis Fischel Cancer Center at University of Missouri - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital at Ohio State University	Columbus	Ohio
United States	Mount Diablo Regional Cancer Center	Concord	California
United States	Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Baylor University Medical Center	Dallas	Texas
United States	Medical City Dallas Hospital	Dallas	Texas
United States	Parkland Health and Hospital System	Dallas	Texas
United States	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	St. Paul University Hospital	Dallas	Texas
United States	Zale Lipshy University Hospital	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Miami Valley Hospital	Dayton	Ohio
United States	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Health System	Detroit	Michigan
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Easton Hospital	Easton	Pennsylvania
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	Evanston Northwestern Health Care - Evanston Hospital	Evanston	Illinois
United States	Deaconess Hospital	Evansville	Indiana
United States	St. Mary's Medical Center	Evansville	Indiana
United States	INOVA Fair Oaks Hospital	Fairfax	Virginia
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	Great Lakes Cancer Institute - McLaren	Flint	Michigan
United States	Surgical Oncology of Northeast Georgia	Gainesville	Georgia
United States	University of Texas Medical Branch	Galveston	Texas
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Butterworth Hospital	Grand Rapids	Michigan
United States	Spectrum Health - Blodgett Campus	Grand Rapids	Michigan
United States	Spectrum Health Downtown Campus	Grand Rapids	Michigan
United States	Kaiser Permanente Medical Center	Honolulu	Hawaii
United States	St. Francis Medical Center	Honolulu	Hawaii
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
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	Fern Feldman Anolick Breast Center at Benedictine Hospital	Kingston	New York
United States	Kingston Hospital	Kingston	New York
United States	Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center	La Crosse	Wisconsin
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Watson Clinic	Lakeland	Florida
United States	Doctor's Hospital of Laredo	Laredo	Texas
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Baptist Health Medical Center	Little Rock	Arkansas
United States	St. Vincent Doctors Doctors Hospital	Little Rock	Arkansas
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Norton Healthcare Cancer Center	Louisville	Kentucky
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	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Marlton	New Jersey
United States	Baptist Cancer Institute at Baptist Memorial Hospital - Memphis	Memphis	Tennessee
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Vince Lombardi Cancer Clinic at St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Providence Cancer Center	Mobile	Alabama
United States	West Virginia University Hospitals	Morgantown	West Virginia
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	Southern New Hampshire Medical Center	Nashua	New Hampshire
United States	Baptist Hospital	Nashville	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	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Summit Medical Center	Oakland	California
United States	McKay-Dee Hospital Center	Ogden	Utah
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	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center at Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Medical Office - Mother Joseph Plaza	Portland	Oregon
United States	Maine Medical Center	Portland	Maine
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Women and Infants Hospital of Rhode Island	Providence	Rhode Island
United States	Shasta Regional Medical Center	Redding	California
United States	Carilion Health System - Cancer Center of Western Virginia	Roanoke	Virginia
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	University of California Davis Cancer Center	Sacramento	California
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	St. Louis University Hospital Cancer Center	Saint Louis	Missouri
United States	Park Nicollet Clinic	Saint Louis Park	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
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	CCOP - Mayo Clinic Scottsdale Oncology Program	Scottsdale	Arizona
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington
United States	Sonoma Valley Hospital	Sonoma	California
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	Mount Nittany Medical Center	State College	Pennsylvania
United States	St. Joseph's Regional Cancer Center	Stockton	California
United States	Martin Memorial Cancer Center	Stuart	Florida
United States	Flower Hospital - ProMedica Health System	Sylvania	Ohio
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Toledo Hospital	Toledo	Ohio
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Lombardi Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Henry Ford Medical Center - West Bloomfield	West Bloomfield	Michigan
United States	Williamsport Hospital	Williamsport	Pennsylvania
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Fallon Clinic at Worcester Medical Center	Worcester	Massachusetts
United States	Greene Memorial Hospital	Xenia	Ohio
United States	Avera Sacred Heart Hospital	Yankton	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Ireland, 

References & Publications (10)

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. — View Citation

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 — View Citation

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. — View Citation

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 tria — View Citation

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 metastase — View Citation

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 involveme — View Citation

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.

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 lym — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 10 years
Primary	Morbidity		Up to 10 years
Primary	Disease-free survival		Up to 10 years

External Links

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