Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Procedure: axillary lymph node dissectionRadiation: whole breast irradiation
- Registration Number
- NCT00003855
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 605
PLEASE NOTE: Patients registered to this study may undergo intra-operative or post¬operative randomization.
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Patient must be female.
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Patient must be at least 18 years of age.
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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.
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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.
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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.
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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.
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Patient must have ECOG/Zubrod status =2, as documented in patient's medical record.
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Patient must be available for follow-up.
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Patient of childbearing potential must have a negative serum or urine pregnancy test within 14 days of beginning study interventions.
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Patient must have access to radiation therapy.
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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.
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Patient randomized to ALND must undergo ALND within 42 days of their SLND.
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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:
- 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.
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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.
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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.
- 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 has concurrent invasive bilateral breast malignancies.
- 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.
- 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.
- Patient who is noted to have matted nodes or gross extranodal disease at the time of SLND.
- Patient has three or more positive sentinel nodes by frozen section, touch prep, or H&E staining on permanent section.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery + radiotherapy whole breast irradiation Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks. Patients may receive adjuvant systemic therapy at the discretion of the treating physician. Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years. Radiotherapy whole breast irradiation Patients undergo breast radiotherapy only. Patients may receive adjuvant systemic therapy at the discretion of the treating physician. Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years. Surgery + radiotherapy axillary lymph node dissection Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks. Patients may receive adjuvant systemic therapy at the discretion of the treating physician. Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.
- Primary Outcome Measures
Name Time Method Overall survival Up to 10 years Morbidity Up to 10 years Disease-free survival Up to 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (155)
Palo Alto Medical Foundation
🇺🇸Palo Alto, California, United States
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Arthur G. James Cancer Hospital at Ohio State University
🇺🇸Columbus, Ohio, United States
UPMC Cancer Center at Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, 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
Shasta Regional Medical Center
🇺🇸Redding, California, United States
St. Joseph Hospital Regional Cancer Center - Orange
🇺🇸Orange, California, United States
Deaconess Hospital
🇺🇸Evansville, Indiana, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Watson Clinic
🇺🇸Lakeland, Florida, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
St. Joseph's Regional Cancer Center
🇺🇸Stockton, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Summit Medical Center
🇺🇸Oakland, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Huntington Cancer Center at Huntington Hospital
🇺🇸Pasadena, California, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
Martin Memorial Cancer Center
🇺🇸Stuart, Florida, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
🇺🇸Albany, Georgia, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Baton Rouge General Regional Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
St. Mary's Medical Center
🇺🇸Evansville, Indiana, United States
Woman's Hospital
🇺🇸Baton Rouge, Louisiana, United States
Belleville Memorial Hospital
🇺🇸Belleville, Illinois, United States
Surgical Oncology of Northeast Georgia
🇺🇸Gainesville, Georgia, United States
DeCesaris Cancer Institute at Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
St. Elizabeth's Hospital
🇺🇸Belleville, Illinois, United States
Easton Hospital
🇺🇸Easton, Pennsylvania, United States
Fallon Clinic at Worcester Medical Center
🇺🇸Worcester, Massachusetts, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
St. Paul University Hospital
🇺🇸Dallas, Texas, United States
Williamsport Hospital
🇺🇸Williamsport, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Kingston Hospital
🇺🇸Kingston, New York, United States
Zale Lipshy University Hospital
🇺🇸Dallas, Texas, United States
St. Luke's Hospital Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
West Virginia University Hospitals
🇺🇸Morgantown, West Virginia, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Carilion New River Valley Medical Center
🇺🇸Christiansburg, Virginia, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Baptist Hospital
🇺🇸Nashville, Tennessee, United States
Sarah Cannon Cancer Center at Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente Medical Office - Mother Joseph Plaza
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Providence Cancer Center
🇺🇸Mobile, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Mount Diablo Regional Cancer Center
🇺🇸Concord, California, United States
Mercy San Juan Hospital
🇺🇸Carmichael, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
Sonoma Valley Hospital
🇺🇸Sonoma, California, United States
John Wayne Cancer Institute at Saint John's Health Center
🇺🇸Santa Monica, California, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Lombardi Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Alexian Brothers Medical Center
🇺🇸Elk Grove Village, Illinois, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, 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
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Great Lakes Cancer Institute - McLaren
🇺🇸Flint, Michigan, United States
Henry Ford Medical Center - West Bloomfield
🇺🇸West Bloomfield, Michigan, United States
Spectrum Health - Blodgett Campus
🇺🇸Grand Rapids, Michigan, United States
Park Nicollet Clinic
🇺🇸Saint Louis Park, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, 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
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
🇺🇸Marlton, New Jersey, United States
Southern New Hampshire Medical Center
🇺🇸Nashua, New Hampshire, United States
Louis Busch Hager Cancer Center at Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Fern Feldman Anolick Breast Center at Benedictine Hospital
🇺🇸Kingston, New York, United States
New York Weill Cornell Cancer Center at Cornell University
🇺🇸New York, New York, 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
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Tri-Health Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Flower Hospital - ProMedica Health System
🇺🇸Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Sacred Heart Hospital
🇺🇸Allentown, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Baptist Cancer Institute at Baptist Memorial Hospital - Memphis
🇺🇸Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Mercy Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Women and Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Avera Sacred Heart Hospital
🇺🇸Yankton, South Dakota, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Parkland Health and Hospital System
🇺🇸Dallas, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Doctor's Hospital of Laredo
🇺🇸Laredo, Texas, United States
Southwest Cancer and Research Center at University Medical Center
🇺🇸Lubbock, Texas, United States
Joe Arrington Cancer Research and Treatment Center
🇺🇸Lubbock, Texas, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Dixie Regional Medical Center
🇺🇸Saint George, Utah, United States
Cancer Center at the University of Virginia
🇺🇸Charlottesville, Virginia, United States
INOVA Fair Oaks Hospital
🇺🇸Fairfax, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Carilion Health System - Cancer Center of Western Virginia
🇺🇸Roanoke, Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Vince Lombardi Cancer Clinic at St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Cork University Hospital
🇮🇪Cork, Ireland
Lutheran Medical Center
🇺🇸Brooklyn, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Butterworth Hospital
🇺🇸Grand Rapids, Michigan, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
St. Francis Hospital and Health Centers
🇺🇸Beech Grove, Indiana, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Evanston Northwestern Health Care - Evanston Hospital
🇺🇸Evanston, Illinois, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
St. Louis University Hospital Cancer Center
🇺🇸Saint Louis, Missouri, United States
Spectrum Health Downtown Campus
🇺🇸Grand Rapids, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Norton Healthcare Cancer Center
🇺🇸Louisville, Kentucky, United States
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
🇺🇸Bronx, New York, United States
St. Francis Medical Center
🇺🇸Honolulu, Hawaii, United States
Kaiser Permanente Medical Center
🇺🇸Honolulu, Hawaii, United States
Seton Shivers Cancer Program at Brackenridge Hospital
🇺🇸Austin, Texas, United States