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Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ Clinical research trials and Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ. Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ clinical trial. Participants oftentimes recieve the most expert healthcare available for their Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ  Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ
Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ
For Condition: Carcinoma, Infiltrating Duct,Breast Neoplasms
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
Details: OBJECTIVES: I. Evaluate actuarial local in situ and invasive recurrence rates at 5 and 10 years after local excision in patients with a favorable ductal carcinoma in situ (DCIS) of the breast prognosis. II. Evaluate concordance between institutional pathologists and central review pathologists with respect to diagnosis and grading of DCIS. III. Identify parameters that indicate increased or decreased risk of recurrence in the absence of irradiation. IV. Evaluate patterns of salvage of recurrence and rates of breast conservation. V. Evaluate actuarial relapse-free, overall, and cause-specific survival at 5 and 10 years post DCIS excision. PROTOCOL 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:
Study Type: Observational, Screening
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LorieHughes, Study Chair, Eastern Cooperative Oncology Group
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
New England Medical Center Hospital
Boston, Massachusetts, 02111
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Additional Information:
Study ID Numbers: CDR0000065370; E-5194
Study Start Date: April 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002934
Other Breast Neoplasms Studies:
1. Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ
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Evaluation of Breast Cancer Recurrence Rates Following Surgery for Ductal Carcinoma In Situ
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