Spots Global Cancer Trial Database for Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
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Trial Identification
Brief Title: Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
Official Title: Local Excision Alone for Selected Patients With DCIS of the Breast
Study ID: NCT00002934
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: The evaluation of breast cancer recurrence rates may improve the ability to plan cancer treatment for patients with breast cancer. PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.
Detailed Description: OBJECTIVES: * Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in women with a favorable ductal carcinoma in situ (DCIS) prognosis. * Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS. * Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation. * Evaluate patterns of salvage of recurrence and rates of breast conservation. * Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision. OUTLINE: This is a registration study stratified by histologic grade (high vs low or intermediate) and adjuvant tamoxifen therapy (yes vs no). Patients receive standard clinical and mammographic follow-up for greater than 10 years. If recurrence occurs, treatment will be at the discretion of the investigators. Patients may receive adjuvant oral tamoxifen daily for 5 years after local excision. A follow up magnification view mammogram must be taken after the last local excision, and microcalcification must be negative. Patients are followed every 6 months for the first 10 years, and then annually thereafter. PROJECTED ACCRUAL: 1000 (500 per stratum) eligible and evaluable patients will be enrolled at an estimated accrual rate of 250 patients per year.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Emory University Hospital - Atlanta, Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
CCOP - Wichita, Wichita, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
CCOP - Duluth, Duluth, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - Oklahoma, Tulsa, Oklahoma, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
CCOP - Green Bay, Green Bay, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Pretoria Academic Hospitals, Pretoria, , South Africa
Contact Details
Name: Lorie L. Hughes, MD
Affiliation: Emory University
Role: STUDY_CHAIR
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