Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With 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.

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