Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Other: immunohistochemistry staining methodProcedure: lymphangiographyProcedure: sentinel lymph node biopsyProcedure: therapeutic conventional surgeryRadiation: whole breast irradiation
- Registration Number
- NCT00003854
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4590
-
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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Surgery + radiotherapy + adjuvant therapy sentinel lymph node biopsy 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. Surgery + radiotherapy + adjuvant therapy immunohistochemistry staining method 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. Surgery + radiotherapy + adjuvant therapy lymphangiography 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. Surgery + radiotherapy + adjuvant therapy therapeutic conventional surgery 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. Surgery + radiotherapy + adjuvant therapy whole breast irradiation 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.
- Primary Outcome Measures
Name Time Method Overall survival Up to 10 years
- Secondary Outcome Measures
Name Time Method Disease-free survival Up to 10 years Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND Up to 10 years
Trial Locations
- Locations (116)
York Cancer Center
🇺🇸York, Pennsylvania, United States
Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Donald N. Sharp Memorial Community Hospital
🇺🇸San Diego, California, United States
Tri-Health Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente Medical Center - Los Angeles
🇺🇸Los Angeles, California, United States
St. Joseph Hospital - Orange
🇺🇸Orange, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Morton Plant Mease Health Care
🇺🇸Clearwater, Florida, United States
Lombardi Cancer Center
🇺🇸Washington, District of Columbia, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Bayfront Medical Center
🇺🇸Saint Petersburg, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Martin Memorial Cancer Medical Center
🇺🇸Stuart, Florida, United States
St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
DeKalb Medical Center, Inc.
🇺🇸Decatur, Georgia, United States
Kaiser Permanente Medical Center
🇺🇸Honolulu, Hawaii, United States
Belleville Memorial Hospital
🇺🇸Belleville, Illinois, United States
St. Francis Medical Center
🇺🇸Honolulu, Hawaii, United States
St. Elizabeth's Hospital
🇺🇸Belleville, 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
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Woman's Hospital
🇺🇸Baton Rouge, Louisiana, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Baton Rouge General Medical Center
🇺🇸Baton Rouge, Louisiana, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, 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
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Durham Regional Hospital
🇺🇸Durham, North Carolina, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Baptist Hospital
🇺🇸Nashville, Tennessee, United States
Latter Day Saints Hospital
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, 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
Providence Hospital - Mobile AL
🇺🇸Mobile, Alabama, United States
St. Vincent Doctors Doctors Hospital
🇺🇸Little Rock, Arkansas, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Summit Medical Center
🇺🇸Oakland, California, United States
Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Henry Ford Medical Center - West Bloomfield
🇺🇸West Bloomfield, Michigan, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Columbia Regional Hospital
🇺🇸Columbia, Missouri, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Mount Holly, New Jersey, United States
Kingston Hospital
🇺🇸Kingston, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Keesler Medical Center - Keesler AFB
🇺🇸Keesler AFB, Mississippi, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Lutheran Medical Center
🇺🇸Brooklyn, New York, United States
Sacred Heart Hospital
🇺🇸Allentown, Pennsylvania, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sarah Cannon-Minnie Pearl Cancer Center
🇺🇸Nashville, Tennessee, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Carilion New River Valley Medical Center
🇺🇸Christiansburg, Virginia, United States
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Peter MacCallum Cancer Institute
🇦🇺East Melbourne, Victoria, Australia
Columbia Lewis-Gale Medical Center
🇺🇸Salem, Virginia, United States
Cork University Hospital
🇮🇪Cork, Ireland
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
University of Missouri-Columbia Hospital and Clinics
🇺🇸Columbia, Missouri, United States
Lester E. Cox Medical Centers
🇺🇸Springfield, Missouri, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Benedictine Hospital
🇺🇸Kingston, New York, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
🇺🇸New York, New York, United States
Park Nicollet Clinic
🇺🇸St. Louis Park, Minnesota, United States
St. Paul University Hospital
🇺🇸Dallas, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Kent County Memorial Hospital
🇺🇸Warwick, Rhode Island, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Cape Fear Valley Health System
🇺🇸Fayetteville, North Carolina, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Northwestern University Medical Center
🇺🇸Chicago, Illinois, United States
Carilion Health System - Cancer Center of Western Virginia
🇺🇸Roanoke, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Norton Healthcare System
🇺🇸Louisville, Kentucky, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Texas Cancer Center at Brackenridge Hospital
🇺🇸Austin, Texas, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States