Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Local Excision Alone for Selected Patients With DCIS of the Breast|
- Actuarial local recurrence rate [ Time Frame: Assessed at 5 years ] [ Designated as safety issue: No ]Rate of in situ or invasive local breast cancer recurrence
|Study Start Date:||April 1997|
|Study Completion Date:||October 2012|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
No Intervention: Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up
|Procedure: long-term screening|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002934
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|Study Chair:||Lorie L. Hughes, MD||Winship Cancer Institute of Emory University|