NCT00002934

Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ

Local Excision Alone for Selected Patients With DCIS of the Breast

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	long-term screening

Timeline

• Start date: 1997-06-25
• Primary completion: 2007-12-01
• Completion: 2012-10-01
• First posted: 2003-04-16
• Last updated: 2023-06-22

Locations

30 sites across 2 countries: United States, South Africa