Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Other: immunohistochemistry staining method Procedure: lymphangiography Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Radiation: whole breast irradiation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Diagnostic |
| Official Title: | A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer |
| Estimated Enrollment: | 5300 |
| Study Start Date: | April 1999 |
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.
OUTLINE: 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.
PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within an additional 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I or IIA (T1 or T2 N0 M0) invasive breast carcinoma diagnosed within 60 days of sentinel lymph node dissection
- Cytologic diagnosis suggestive of carcinoma from a fine needle aspiration of a palpable or nonpalpable breast lesion allowed if clinically suspicious for invasive breast carcinoma
- Tumor must be amenable to segmental mastectomy (lumpectomy)
- No clinically and radiologically identified multicentric disease that is not amenable to a single lumpectomy
- No concurrent bilateral invasive breast malignancies
- No tumors in the medial hemisphere of the breast that show complete absence of drainage to the axilla by lymphoscintigram
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Over 18
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2 OR
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- No renal disease that would increase surgical risk
Cardiovascular:
- No cardiovascular disease that would increase surgical risk
Other:
- No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, surgically treated carcinoma in situ of the cervix, or curatively treated lobular carcinoma in situ of the ipsilateral or contralateral breast with a low risk of recurrence
- No other nonmalignant systemic disease that would increase surgical risk
- No active connective tissue disorders
- Able to undergo and have access to radiotherapy
- Physically able to undergo bilateral anterior iliac crest bone marrow aspiration
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for invasive breast cancer
Endocrine therapy:
- No prior estrogen-receptor antagonists (e.g., tamoxifen) or selective estrogen-receptor modulators (e.g., raloxifene) for invasive breast cancer
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph nodes or treatment of hidradenitis)
- No pre-pectoral breast implant
- Subpectoral implant allowed
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36640-0460 | |
| Providence Hospital - Mobile AL | |
| Mobile, Alabama, United States, 36685 | |
| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, Arkansas | |
| Washington Regional Medical Center | |
| Fayetteville, Arkansas, United States, 72703 | |
| Baptist Health Medical Center | |
| Little Rock, Arkansas, United States, 72205-7200 | |
| St. Vincent Doctors Doctors Hospital | |
| Little Rock, Arkansas, United States, 72205-5331 | |
| United States, California | |
| Kaiser Permanente Medical Center - Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| Summit Medical Center | |
| Oakland, California, United States, 94609 | |
| St. Joseph Hospital - Orange | |
| Orange, California, United States, 92868-3849 | |
| Huntington Memorial Hospital | |
| Pasadena, California, United States, 91109-7013 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Donald N. Sharp Memorial Community Hospital | |
| San Diego, California, United States, 92123 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94143-0128 | |
| John Wayne Cancer Institute | |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Memorial Hospital Cancer Center | |
| Colorado Springs, Colorado, United States, 80909 | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030-3955 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Morton Plant Mease Health Care | |
| Clearwater, Florida, United States, 33756 | |
| Watson Clinic | |
| Lakeland, Florida, United States, 33805 | |
| Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33804 | |
| Bayfront Medical Center | |
| Saint Petersburg, Florida, United States, 33701 | |
| Martin Memorial Cancer Medical Center | |
| Stuart, Florida, United States, 34995 | |
| Tallahassee Memorial Healthcare | |
| Tallahassee, Florida, United States, 32308 | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| DeKalb Medical Center, Inc. | |
| Decatur, Georgia, United States, 30033 | |
| United States, Hawaii | |
| Kaiser Permanente Medical Center | |
| Honolulu, Hawaii, United States, 96819 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Idaho | |
| St. Luke's Regional Medical Center | |
| Boise, Idaho, United States, 83712 | |
| United States, Illinois | |
| Belleville Memorial Hospital | |
| Belleville, Illinois, United States, 62226-5399 | |
| St. Elizabeth's Hospital | |
| Belleville, Illinois, United States, 62220-1998 | |
| Northwestern University Medical Center | |
| Chicago, Illinois, United States, 60611 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| CCOP - Evanston | |
| Evanston, Illinois, United States, 60201 | |
| Little Company of Mary Hospital - Evergreen Park | |
| Evergreen Park, Illinois, United States, 60805-2746 | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Saint Anthony Memorial Health Center - Michigan City Campus | |
| Michigan City, Indiana, United States, 46360 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Kentucky | |
| Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503-9985 | |
| James Graham Brown Cancer Center | |
| Louisville, Kentucky, United States, 40202 | |
| Norton Healthcare System | |
| Louisville, Kentucky, United States, 40202-5070 | |
| United States, Louisiana | |
| Baton Rouge General Medical Center | |
| Baton Rouge, Louisiana, United States, 70821-2511 | |
| Woman's Hospital | |
| Baton Rouge, Louisiana, United States, 70815 | |
| United States, Maryland | |
| Anne Arundel Medical Center | |
| Annapolis, Maryland, United States, 21401 | |
| United States, Massachusetts | |
| Lahey Clinic - Burlington | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| McLaren Regional Cancer Center | |
| Flint, Michigan, United States, 48432 | |
| Genesys Regional Medical Center | |
| Grand Blanc, Michigan, United States, 48439-8066 | |
| Spectrum Health - Butterworth Campus | |
| Grand Rapids, Michigan, United States, 49546 | |
| Henry Ford Medical Center - West Bloomfield | |
| West Bloomfield, Michigan, United States, 48322 | |
| United States, Minnesota | |
| Park Nicollet Clinic | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Mississippi | |
| Keesler Medical Center - Keesler AFB | |
| Keesler AFB, Mississippi, United States, 39534-2576 | |
| Singing River Hospital | |
| Pascagoula, Mississippi, United States, 39581 | |
| United States, Missouri | |
| Ellis Fischel Cancer Center - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Columbia Regional Hospital | |
| Columbia, Missouri, United States, 65201 | |
| University of Missouri-Columbia Hospital and Clinics | |
| Columbia, Missouri, United States, 65212 | |
| Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| St. Louis University Health Sciences Center | |
| Saint Louis, Missouri, United States, 63110-2500 | |
| Lester E. Cox Medical Centers | |
| Springfield, Missouri, United States, 65807-1988 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital | |
| Mount Holly, New Jersey, United States, 08060 | |
| United States, New York | |
| Lutheran Medical Center | |
| Brooklyn, New York, United States, 11220 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Benedictine Hospital | |
| Kingston, New York, United States, 12401 | |
| Kingston Hospital | |
| Kingston, New York, United States, 12401-4692 | |
| New York Presbyterian Hospital - Cornell Campus | |
| New York, New York, United States, 10021 | |
| St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |
| New York, New York, United States, 10019 | |
| Highland Hospital of Rochester | |
| Rochester, New York, United States, 14620 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| Durham Regional Hospital | |
| Durham, North Carolina, United States, 27704-2763 | |
| Cape Fear Valley Health System | |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| United States, Ohio | |
| Tri-Health Good Samaritan Hospital | |
| Cincinnati, Ohio, United States, 90027 | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210-1228 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| United States, Pennsylvania | |
| Sacred Heart Hospital | |
| Allentown, Pennsylvania, United States, 18102 | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Mercy Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| York Cancer Center | |
| York, Pennsylvania, United States, 17403 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| Kent County Memorial Hospital | |
| Warwick, Rhode Island, United States, 02886 | |
| United States, Tennessee | |
| Baptist Hospital | |
| Nashville, Tennessee, United States, 37236 | |
| Sarah Cannon-Minnie Pearl Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| Texas Cancer Center at Brackenridge Hospital | |
| Austin, Texas, United States, 78701 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| St. Paul University Hospital | |
| Dallas, Texas, United States, 75235 | |
| Zale Lipshy University Hospital | |
| Dallas, Texas, United States, 75235-7786 | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555-0542 | |
| Ben Taub General Hospital | |
| Houston, Texas, United States, 77030 | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| Joe Arrington Cancer Research and Treatment Center | |
| Lubbock, Texas, United States, 79410-1894 | |
| United States, Utah | |
| Huntsman Cancer Institute | |
| Salt Lake City, Utah, United States, 84132 | |
| Latter Day Saints Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
| United States, Virginia | |
| Cancer Center at the University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Carilion New River Valley Medical Center | |
| Christiansburg, Virginia, United States, 24073 | |
| Inova Fairfax Hospital | |
| Falls Church, Virginia, United States, 22042-3300 | |
| Carilion Health System - Cancer Center of Western Virginia | |
| Roanoke, Virginia, United States, 24033 | |
| Columbia Lewis-Gale Medical Center | |
| Salem, Virginia, United States, 24153 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Froedtert Memorial Lutheran Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| St. Luke's Medical Center | |
| Milwaukee, Wisconsin, United States, 53215-5166 | |
| Aurora Sinai Medical Center | |
| Milwaukee, Wisconsin, United States, 53201-0342 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Institute | |
| East Melbourne, Victoria, Australia, 8006 | |
| Ireland | |
| Cork University Hospital | |
| Cork, Ireland | |
| St. Vincent's University Hospital | |
| Dublin, Ireland, 4 | |
| Study Chair: | Armando E. Giuliano, MD | John Wayne Cancer Institute at Saint John's Health Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003854 History of Changes |
| Other Study ID Numbers: | CDR0000067017, ACOSOG-Z0010, GUMC-00152 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 18, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IA breast cancer stage IB breast cancer stage II breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 18, 2013