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	Treatment or Intervention
Breast Neoplasms Carcinoma, Infiltrating Duct	Procedure: screening  Procedure: screening intervention  Drug: long-term screening

Further Study Details: 

OBJECTIVES: I. Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in patients with a favorable ductal carcinoma in situ (DCIS) of the breast prognosis. II. Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS. III. Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation. IV. Evaluate patterns of salvage of recurrence and rates of breast conservation. V. Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision.

PROTOCOL 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 above,  Genders Eligible for Study:  Female

Criteria

PROTOCOL ENTRY 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

--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

--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

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
Illinois
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States
      Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis,  Indiana,  46202,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States
Michigan
      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
New Jersey
      Cancer Institute of New Jersey, New Brunswick,  New Jersey,  08903,  United States
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States
Pennsylvania
      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104-4283,  United States
Tennessee
      Vanderbilt-Ingram Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus, Nashville,  Tennessee,  37212,  United States
Wisconsin
      CCOP - Green Bay, Green Bay,  Wisconsin,  54301,  United States
      CCOP - Marshfield Medical Research and Education Foundation, Marshfield,  Wisconsin,  54449,  United States
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States
South Africa
      Pretoria Academic Hospitals, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Lorie L. Hughes,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000065370; E-5194
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002934
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08