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Local Excision Alone for Selected Patients With DCIS of the Breast


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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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 - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - WichitaWichita, Kansas  67214-3882
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
New England Medical Center HospitalBoston, Massachusetts  02111
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - DuluthDuluth, Minnesota  55805
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Medical College of WisconsinMilwaukee, Wisconsin  53226
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
CCOP - Green BayGreen Bay, Wisconsin  54301
CCOP - OklahomaTulsa, Oklahoma  74136
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212