Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
NCT ID: NCT00003854
Last Updated: 2016-07-13
Study Results
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Basic Information
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COMPLETED
PHASE3
4590 participants
INTERVENTIONAL
1999-04-30
2011-07-31
Brief Summary
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PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.
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Detailed Description
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* Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer.
* Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.
* Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H\&E) staining.
* Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H\&E so that these women can be considered as candidates for ACOSOG-Z0011.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Surgery + radiotherapy + adjuvant therapy
Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology.
Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H\&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes.
All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks.
Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually until 10 years after surgery.
immunohistochemistry staining method
lymphangiography
sentinel lymph node biopsy
therapeutic conventional surgery
whole breast irradiation
Interventions
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immunohistochemistry staining method
lymphangiography
sentinel lymph node biopsy
therapeutic conventional surgery
whole breast irradiation
Eligibility Criteria
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Inclusion Criteria
2. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (lumpectomy).
3. 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.
4. The date of the patient's first tissue diagnosis of invasive breast carcinoma or cytologic diagnosis of breast carcinoma must be no more than 60 days prior to SLND.
5. The patient who had segmental mastectomy (lumpectomy) performed previously, and is now referred to the local investigator for SLND, is eligible if the lumpectomy was less than or equal to 60 days prior to the SLND. Copies of the operative and pathology reports must be submitted as a part of the registration process.
6. Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record.
7. Patient must be available for follow-up.
8. The 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.
9. Signed and dated informed consent is obtained prior to patient registration.
10. Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
11. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration.
Exclusion Criteria
2. Patient has been previously treated with chemotherapy, estrogen receptor antagonists (i.e. Tamoxifen) or selective estrogen receptor modulators (SERMs, i.e. Raloxifene) for this invasive breast cancer.
3. Patient has a previously placed pre-pectoral breast implant. NOTE: A subpectoral implant is allowed.
4. Patient is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options.
5. Patient has concurrent bilateral invasive breast malignancies.
6. Patient is not able to undergo and does not have access to radiation therapy as describedin Adjuvant Radiation Therapy in the Interventions section of the protocol.
Patients with active connective tissue disorders and those that live too far from a radiation treatment center, for example, would not be eligible.
7. Patient has clinically and radiologically identified multi-centric disease that is not amenable to a single lumpectomy.
8. Patient has had previous ipsilateral axillary surgery such as excisional biopsy of lymph node(s), treatment of hidradenitis.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Armando E. Giuliano, MD
Role: STUDY_CHAIR
Saint John's Cancer Institute
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Providence Hospital - Mobile AL
Mobile, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Washington Regional Medical Center
Fayetteville, Arkansas, United States
St. Vincent Doctors Doctors Hospital
Little Rock, Arkansas, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States
Summit Medical Center
Oakland, California, United States
St. Joseph Hospital - Orange
Orange, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Donald N. Sharp Memorial Community Hospital
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Memorial Hospital Cancer Center
Colorado Springs, Colorado, United States
University of Colorado Cancer Center
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States
Lombardi Cancer Center
Washington D.C., District of Columbia, United States
Morton Plant Mease Health Care
Clearwater, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Watson Clinic
Lakeland, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
Martin Memorial Cancer Medical Center
Stuart, Florida, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
DeKalb Medical Center, Inc.
Decatur, Georgia, United States
St. Francis Medical Center
Honolulu, Hawaii, United States
Kaiser Permanente Medical Center
Honolulu, Hawaii, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
St. Elizabeth's Hospital
Belleville, Illinois, United States
Belleville Memorial Hospital
Belleville, Illinois, United States
Northwestern University Medical Center
Chicago, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
Evanston Northwestern Health Care
Evanston, Illinois, United States
Little Company of Mary Hospital - Evergreen Park
Evergreen Park, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Saint Anthony Memorial Health Center - Michigan City Campus
Michigan City, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Norton Healthcare System
Louisville, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Woman's Hospital
Baton Rouge, Louisiana, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Lahey Clinic - Burlington
Burlington, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
McLaren Regional Cancer Center
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Spectrum Health - Butterworth Campus
Grand Rapids, Michigan, United States
Henry Ford Medical Center - West Bloomfield
West Bloomfield, Michigan, United States
Park Nicollet Clinic
Saint Louis Park, Minnesota, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Singing River Hospital
Pascagoula, Mississippi, United States
Columbia Regional Hospital
Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States
Lester E. Cox Medical Centers
Springfield, Missouri, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States
Lutheran Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Kingston Hospital
Kingston, New York, United States
Benedictine Hospital
Kingston, New York, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Durham Regional Hospital
Durham, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Tri-Health Good Samaritan Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Sacred Heart Hospital
Allentown, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
York Cancer Center
York, Pennsylvania, United States
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Kent County Memorial Hospital
Warwick, Rhode Island, United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Baptist Hospital
Nashville, Tennessee, United States
Texas Cancer Center at Brackenridge Hospital
Austin, Texas, United States
Zale Lipshy University Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
St. Paul University Hospital
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Methodist Hospital
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Latter Day Saints Hospital
Salt Lake City, Utah, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Carilion New River Valley Medical Center
Christiansburg, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Health System - Cancer Center of Western Virginia
Roanoke, Virginia, United States
Columbia Lewis-Gale Medical Center
Salem, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia
Cork University Hospital
Cork, , Ireland
St. Vincent's University Hospital
Dublin, , Ireland
Countries
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References
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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.
Hunt KK, Ballman KV, McCall LM, Boughey JC, Mittendorf EA, Cox CE, Whitworth PW, Beitsch PD, Leitch AM, Buchholz TA, Morrow MA, Giuliano AE. Factors associated with local-regional recurrence after a negative sentinel node dissection: results of the ACOSOG Z0010 trial. Ann Surg. 2012 Sep;256(3):428-36. doi: 10.1097/SLA.0b013e3182654494.
Giuliano AE, Hawes D, Ballman KV, Whitworth PW, Blumencranz PW, Reintgen DS, Morrow M, Leitch AM, Hunt KK, McCall LM, Abati A, Cote R. Association of occult metastases in sentinel lymph nodes and bone marrow with survival among women with early-stage invasive breast cancer. JAMA. 2011 Jul 27;306(4):385-93. doi: 10.1001/jama.2011.1034.
Wilke LG, Ballman KV, McCall LM, Giuliano AE, Whitworth PW, Blumencranz PW, Reintgen DS, Burak WE, Leitch AM, Hunt KK. Adherence to the National Quality Forum (NQF) breast cancer measures within cancer clinical trials: a review from ACOSOG Z0010. Ann Surg Oncol. 2010 Aug;17(8):1989-94. doi: 10.1245/s10434-010-0980-9. Epub 2010 Mar 23.
Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol. 2006 Apr;13(4):491-500. doi: 10.1245/ASO.2006.05.013. Epub 2006 Mar 2.
Leitch AM, Beitsch PD, McCall LM, Posther K, Newman LA, Herndon JE 2nd, Hunt KK, Giuliano AE. Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer. Am J Surg. 2005 Oct;190(4):539-42. doi: 10.1016/j.amjsurg.2005.06.024.
Posther KE, McCall LM, Blumencranz PW, Burak WE Jr, Beitsch PD, Hansen NM, Morrow M, Wilke LG, Herndon JE 2nd, Hunt KK, Giuliano AE. Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early-stage breast cancer. Ann Surg. 2005 Oct;242(4):593-9; discussion 599-602. doi: 10.1097/01.sla.0000184210.68646.77.
Katz MS, McCall L, Ballman K, Jagsi R, Haffty BG, Giuliano AE. Nomogram-based estimate of axillary nodal involvement in ACOSOG Z0011 (Alliance): validation and association with radiation protocol variations. Breast Cancer Res Treat. 2020 Apr;180(2):429-436. doi: 10.1007/s10549-020-05555-z. Epub 2020 Feb 10.
Other Identifiers
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GUMC-00152
Identifier Type: -
Identifier Source: secondary_id
CDR0000067017
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACOSOG-Z0010
Identifier Type: -
Identifier Source: org_study_id
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