Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
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|ClinicalTrials.gov Identifier: NCT00002934|
Recruitment Status : Terminated (This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.)
First Posted : April 16, 2003
Last Update Posted : October 8, 2015
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 or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: long-term screening||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||711 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Local Excision Alone for Selected Patients With DCIS of the Breast|
|Study Start Date :||April 1997|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||October 2012|
No Intervention: Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up
Procedure: long-term screening
- Actuarial local recurrence rate [ Time Frame: Assessed at 5 years ]Rate of in situ or invasive local breast cancer recurrence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002934
|Study Chair:||Lorie L. Hughes, MD||Emory University|