Local Excision Alone for Selected Patients With DCIS of the Breast
18 Years
N/A
Female
Breast Cancer
Trial Information
Local Excision Alone for Selected Patients With DCIS of the Breast
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically proven low or intermediate grade ductal carcinoma in situ (DCIS) of
the breast
- No greater than 2.5 cm in the greatest dimension
- OR
- Histologically proven high-grade DCIS of the breast
- No greater than 1 cm in greatest dimension
- Region of DCIS must be at least 2.5 mm in greatest dimension (mammographic estimate
of size allowed where pathologic measurement is impossible)
- DCIS must be non-palpable; detected by a mammogram or found incidentally by a breast
biopsy
- Pathologically confirmed negative margins of at least 3 mm
- Breast must be suitable for breast conserving therapy
- Proper tumor size versus breast size
- No carcinoma or suspicious mammogram findings in other breast sites
- No prior in situ or invasive breast cancer
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Greater than 5 years
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- Not specified
Other:
- No other invasive malignancies within the past 10 years except nonmelanomatous skin
cancer or carcinoma in situ of the cervix
- No known HIV infection
- No Paget's nipple disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Adjuvant tamoxifen allowed
Radiotherapy:
- No prior radiotherapy to breast
- No adjuvant radiotherapy
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Actuarial local recurrence rate
Outcome Description:
Rate of in situ or invasive local breast cancer recurrence
Outcome Time Frame:
Assessed at 5 years
Safety Issue:
No
Principal Investigator
Lorie L. Hughes, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Winship Cancer Institute of Emory University
Authority:
United States: Federal Government
Study ID:
CDR0000065370
NCT ID:
NCT00002934
Start Date:
April 1997
Completion Date:
Related Keywords:
- Breast Cancer
- breast cancer in situ
- ductal breast carcinoma
- Breast Neoplasms
- Carcinoma in Situ
- Carcinoma, Intraductal, Noninfiltrating
Name | Location |
|---|---|
| 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 |
