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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Local Excision Alone for Selected Patients With DCIS of the Breast

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: long-term screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pathology Review, Observation and Follow-up<br>Pathology review, observation and follow-up | Procedure: long-term screening<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actuarial local recurrence rate | Rate of in situ or invasive local breast cancer recurrence | Assessed at 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer in situ, ductal breast carcinoma