Finding studies
Finding studies
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Lead
Eastern Cooperative Oncology Group
With
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.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted