Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
- Conditions
- Breast Cancer
- Interventions
- Procedure: long-term screening
- Registration Number
- NCT00002934
- Lead Sponsor
- Eastern Cooperative Oncology Group
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 711
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pathology Review, Observation and Follow-up long-term screening Pathology review, observation and follow-up
- Primary Outcome Measures
Name Time Method Actuarial local recurrence rate Assessed at 5 years Rate of in situ or invasive local breast cancer recurrence
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - Green Bay
🇺🇸Green Bay, Wisconsin, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Pretoria Academic Hospitals
🇿🇦Pretoria, South Africa
Ireland Cancer Center
🇺🇸Cleveland, Ohio, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
CCOP - Evanston
🇺🇸Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
CCOP - Oklahoma
🇺🇸Tulsa, Oklahoma, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
🇺🇸Wynnewood, Pennsylvania, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
🇺🇸Milwaukee, Wisconsin, United States
CCOP - Ann Arbor Regional
🇺🇸Ann Arbor, Michigan, United States