Breast Cancer Clinical Trial
Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
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.
Full 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.
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
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There are 29 Locations for this study
Atlanta Georgia, 30322, United States
Decatur Georgia, 30033, United States
Evanston Illinois, 60201, United States
Peoria Illinois, 61602, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46202, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50309, United States
Wichita Kansas, 67214, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48106, United States
Kalamazoo Michigan, 49007, United States
Duluth Minnesota, 55805, United States
Saint Louis Park Minnesota, 55416, United States
Hackensack New Jersey, 07601, United States
New Brunswick New Jersey, 08903, United States
Cleveland Ohio, 44106, United States
Tulsa Oklahoma, 74136, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19111, United States
Wynnewood Pennsylvania, 19096, United States
Nashville Tennessee, 37212, United States
Nashville Tennessee, 37232, United States
Green Bay Wisconsin, 54301, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Pretoria , 0001, South Africa
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