Breast Cancer
Conditions
Keywords
breast cancer in situ, ductal breast carcinoma
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURElong-term screening
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Actuarial local recurrence rate | Assessed at 5 years | Rate of in situ or invasive local breast cancer recurrence |
Countries
South Africa, United States
Outcome results
None listed