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

Breast Cancer Clinical Trial

Official title: Local Excision Alone for Selected Patients With DCIS of the Breast

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00002934
• Study type: Interventional
• Source: Eastern Cooperative Oncology Group
• Status: Terminated
• Phase: Phase 2
• Start date: June 25, 1997
• Completion date: October 2012