Local Excision Alone for Selected Patients With DCIS of the Breast
- 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Actuarial local recurrence rate
Rate of in situ or invasive local breast cancer recurrence
Assessed at 5 years
Lorie L. Hughes, MD
Winship Cancer Institute of Emory University
United States: Federal Government
|Emory University Hospital - Atlanta||Atlanta, Georgia 30322|
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|CCOP - Ann Arbor Regional||Ann Arbor, Michigan 48106|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|University of Pennsylvania Cancer Center||Philadelphia, Pennsylvania 19104|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|Veterans Affairs Medical Center - Atlanta (Decatur)||Decatur, Georgia 30033|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|Veterans Affairs Medical Center - Indianapolis (Roudebush)||Indianapolis, Indiana 46202|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|New England Medical Center Hospital||Boston, Massachusetts 02111|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|CCOP - Duluth||Duluth, Minnesota 55805|
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|CCOP - MainLine Health||Wynnewood, Pennsylvania 19096|
|Veterans Affairs Medical Center - Milwaukee (Zablocki)||Milwaukee, Wisconsin 53295|
|CCOP - Evanston||Evanston, Illinois 60201|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|CCOP - Marshfield Medical Research and Education Foundation||Marshfield, Wisconsin 54449|
|CCOP - Green Bay||Green Bay, Wisconsin 54301|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus||Nashville, Tennessee 37212|