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Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
immunohistochemistry staining method
lymphangiography
sentinel lymph node biopsy
therapeutic conventional surgery
whole breast irradiation
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patient must be female. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (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. 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. 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. Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record. Patient must be available for follow-up. 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: The patient has undergone potentially curative therapy for all prior malignancies. 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 The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. Signed and dated informed consent is obtained prior to patient registration. Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration. Exclusion Criteria: 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 is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options. Patient has concurrent bilateral invasive breast malignancies. 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. 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.

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Mobile Infirmary Medical Center
  • Providence Hospital - Mobile AL
  • Mayo Clinic Scottsdale
  • Washington Regional Medical Center
  • St. Vincent Doctors Doctors Hospital
  • Baptist Health Medical Center
  • Kaiser Permanente Medical Center - Los Angeles
  • Summit Medical Center
  • St. Joseph Hospital - Orange
  • Huntington Memorial Hospital
  • University of California Davis Cancer Center
  • Donald N. Sharp Memorial Community Hospital
  • UCSF Comprehensive Cancer Center
  • John Wayne Cancer Institute
  • Memorial Hospital Cancer Center
  • University of Colorado Cancer Center
  • University of Connecticut Health Center
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center
  • Morton Plant Mease Health Care
  • Lakeland Regional Medical Center
  • Watson Clinic
  • Bayfront Medical Center
  • Martin Memorial Cancer Medical Center
  • Tallahassee Memorial Healthcare
  • H. Lee Moffitt Cancer Center and Research Institute
  • DeKalb Medical Center, Inc.
  • St. Francis Medical Center
  • Kaiser Permanente Medical Center
  • St. Luke's Regional Medical Center
  • St. Elizabeth's Hospital
  • Belleville Memorial Hospital
  • Northwestern University Medical Center
  • CCOP - Evanston
  • Evanston Northwestern Health Care
  • Little Company of Mary Hospital - Evergreen Park
  • Loyola University Medical Center
  • Saint Anthony Memorial Health Center - Michigan City Campus
  • University of Kansas Medical Center
  • Central Baptist Hospital
  • Norton Healthcare System
  • James Graham Brown Cancer Center
  • Woman's Hospital
  • Baton Rouge General Medical Center
  • Anne Arundel Medical Center
  • Lahey Clinic - Burlington
  • Barbara Ann Karmanos Cancer Institute
  • Henry Ford Hospital
  • McLaren Regional Cancer Center
  • Genesys Regional Medical Center
  • Spectrum Health - Butterworth Campus
  • Henry Ford Medical Center - West Bloomfield
  • Park Nicollet Clinic
  • Keesler Medical Center - Keesler AFB
  • Singing River Hospital
  • Columbia Regional Hospital
  • Ellis Fischel Cancer Center - Columbia
  • University of Missouri-Columbia Hospital and Clinics
  • St. Louis University Health Sciences Center
  • Barnes-Jewish Hospital
  • Lester E. Cox Medical Centers
  • Norris Cotton Cancer Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
  • Lutheran Medical Center
  • Roswell Park Cancer Institute
  • Kingston Hospital
  • Benedictine Hospital
  • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
  • New York Presbyterian Hospital - Cornell Campus
  • Highland Hospital of Rochester
  • University of Rochester Medical Center
  • Lineberger Comprehensive Cancer Center, UNC
  • Carolinas Medical Center
  • Durham Regional Hospital
  • Duke Comprehensive Cancer Center
  • Cape Fear Valley Health System
  • Tri-Health Good Samaritan Hospital
  • Ireland Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • Toledo Hospital
  • St. Vincent Mercy Medical Center
  • Sacred Heart Hospital
  • Fox Chase Cancer Center
  • Mercy Hospital of Pittsburgh
  • York Cancer Center
  • Women and Infants Hospital of Rhode Island
  • Kent County Memorial Hospital
  • Sarah Cannon-Minnie Pearl Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • Baptist Hospital
  • Texas Cancer Center at Brackenridge Hospital
  • Zale Lipshy University Hospital
  • Simmons Cancer Center - Dallas
  • St. Paul University Hospital
  • Baylor University Medical Center
  • University of Texas Medical Branch
  • University of Texas - MD Anderson Cancer Center
  • Ben Taub General Hospital
  • Methodist Hospital
  • Joe Arrington Cancer Research and Treatment Center
  • Huntsman Cancer Institute
  • Latter Day Saints Hospital
  • Cancer Center at the University of Virginia
  • Carilion New River Valley Medical Center
  • Inova Fairfax Hospital
  • Carilion Health System - Cancer Center of Western Virginia
  • Columbia Lewis-Gale Medical Center
  • University of Washington Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • Aurora Sinai Medical Center
  • St. Luke's Medical Center
  • Froedtert Memorial Lutheran Hospital
  • Peter MacCallum Cancer Institute
  • Cork University Hospital
  • St. Vincent's University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery + radiotherapy + adjuvant therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Disease-free survival
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND

Full Information

First Posted
November 1, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003854
Brief Title
Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Official Title
A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer. 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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IA breast cancer, stage IB breast cancer, stage II breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4590 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery + radiotherapy + adjuvant therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Procedure
Intervention Name(s)
lymphangiography
Intervention Type
Procedure
Intervention Name(s)
sentinel lymph node biopsy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Type
Radiation
Intervention Name(s)
whole breast irradiation
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Time Frame
Up to 10 years
Title
Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND
Time Frame
Up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be female. Patient's clinical stage must be I or II (T1 or T2 N0 M0) and the tumor must be amenable to segmental mastectomy (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. 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. 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. Patient must have ECOG/Zubrod status of ≤2, as documented in patient's medical record. Patient must be available for follow-up. 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: The patient has undergone potentially curative therapy for all prior malignancies. 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 The patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies. Signed and dated informed consent is obtained prior to patient registration. Patients of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions. Patient must be able to physically undergo bilateral anterior iliac crest bone marrow aspiration. Exclusion Criteria: 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 is considered a poor surgical risk due to a non-malignant systemic disease (cardiovascular, renal, etc.), which would preclude the treatment options. Patient has concurrent bilateral invasive breast malignancies. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armando E. Giuliano, MD
Organizational Affiliation
Saint John's Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36640-0460
Country
United States
Facility Name
Providence Hospital - Mobile AL
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36685
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Washington Regional Medical Center
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
St. Vincent Doctors Doctors Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-5331
Country
United States
Facility Name
Baptist Health Medical Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-7200
Country
United States
Facility Name
Kaiser Permanente Medical Center - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Summit Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
St. Joseph Hospital - Orange
City
Orange
State/Province
California
ZIP/Postal Code
92868-3849
Country
United States
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91109-7013
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Donald N. Sharp Memorial Community Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-3955
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Morton Plant Mease Health Care
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33804
Country
United States
Facility Name
Watson Clinic
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Bayfront Medical Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Martin Memorial Cancer Medical Center
City
Stuart
State/Province
Florida
ZIP/Postal Code
34995
Country
United States
Facility Name
Tallahassee Memorial Healthcare
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
DeKalb Medical Center, Inc.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
St. Francis Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
St. Elizabeth's Hospital
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62220-1998
Country
United States
Facility Name
Belleville Memorial Hospital
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226-5399
Country
United States
Facility Name
Northwestern University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Evanston Northwestern Health Care
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Little Company of Mary Hospital - Evergreen Park
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805-2746
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Saint Anthony Memorial Health Center - Michigan City Campus
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503-9985
Country
United States
Facility Name
Norton Healthcare System
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-5070
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Woman's Hospital
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70815
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70821-2511
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Lahey Clinic - Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
McLaren Regional Cancer Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48432
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439-8066
Country
United States
Facility Name
Spectrum Health - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Henry Ford Medical Center - West Bloomfield
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Park Nicollet Clinic
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Keesler Medical Center - Keesler AFB
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Singing River Hospital
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Columbia Regional Hospital
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
University of Missouri-Columbia Hospital and Clinics
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-2500
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Lester E. Cox Medical Centers
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807-1988
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Lutheran Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Kingston Hospital
City
Kingston
State/Province
New York
ZIP/Postal Code
12401-4692
Country
United States
Facility Name
Benedictine Hospital
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Highland Hospital of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Durham Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704-2763
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cape Fear Valley Health System
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
Tri-Health Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
90027
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1228
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
St. Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Sacred Heart Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Mercy Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
York Cancer Center
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Women and Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Kent County Memorial Hospital
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Sarah Cannon-Minnie Pearl Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Baptist Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37236
Country
United States
Facility Name
Texas Cancer Center at Brackenridge Hospital
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Zale Lipshy University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-7786
Country
United States
Facility Name
Simmons Cancer Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9154
Country
United States
Facility Name
St. Paul University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0542
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1894
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Latter Day Saints Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Carilion New River Valley Medical Center
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Facility Name
Carilion Health System - Cancer Center of Western Virginia
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24033
Country
United States
Facility Name
Columbia Lewis-Gale Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201-0342
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215-5166
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Peter MacCallum Cancer Institute
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
4
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18640934
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.
Results Reference
background
PubMed Identifier
22868365
Citation
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.
Results Reference
result
PubMed Identifier
21791687
Citation
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.
Results Reference
result
PubMed Identifier
20309640
Citation
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.
Results Reference
result
PubMed Identifier
16514477
Citation
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.
Results Reference
result
PubMed Identifier
16164916
Citation
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.
Results Reference
result
PubMed Identifier
16192820
Citation
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.
Results Reference
result
PubMed Identifier
32043193
Citation
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. Erratum In: Breast Cancer Res Treat. 2021 Feb;185(3):891.
Results Reference
derived

Learn more about this trial

Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

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