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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002934 |
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.
Condition | Intervention |
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Breast Cancer |
Procedure: long-term screening |
Study Type: | Interventional |
Study Design: | Screening |
Official Title: | Local Excision Alone for Selected Patients With DCIS of the Breast |
Estimated Enrollment: | 1000 |
Study Start Date: | April 1997 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of the breast
Histologically proven high-grade DCIS of the breast
Breast must be suitable for breast conserving therapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Lorie L. Hughes, MD | Emory University |
Study ID Numbers: | CDR0000065370, E-5194 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002934 |
Health Authority: | United States: Federal Government |
breast cancer in situ ductal breast carcinoma |
Carcinoma, Ductal Skin Diseases Carcinoma in Situ Breast Neoplasms Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating |
Adenocarcinoma Breast Diseases Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary |