Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ

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.

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.

Eligibility 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