Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
NCT ID: NCT00002934
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
711 participants
INTERVENTIONAL
1997-06-25
2012-10-31
Brief Summary
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PURPOSE: Study to evaluate the rate of recurrence of breast cancer in women who have had surgery for ductal carcinoma in situ.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up
long-term screening
Interventions
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long-term screening
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Lorie L. Hughes, MD
Role: STUDY_CHAIR
Emory University
Locations
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Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
New England Medical Center Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Duluth
Duluth, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
CCOP - Green Bay
Green Bay, Wisconsin, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
Pretoria Academic Hospitals
Pretoria, , South Africa
Countries
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References
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Hughes LL, Wang M, Page DL, Gray R, Solin LJ, Davidson NE, Lowen MA, Ingle JN, Recht A, Wood WC. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Nov 10;27(32):5319-24. doi: 10.1200/JCO.2009.21.8560. Epub 2009 Oct 13.
Hughes L, Wang M, Page D, et al.: Five year results of intergroup study E5194: local excision alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS). [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-29, S15, 2006.
Solin LJ, Gray R, Hughes LL, Wood WC, Lowen MA, Badve SS, Baehner FL, Ingle JN, Perez EA, Recht A, Sparano JA, Davidson NE. Surgical Excision Without Radiation for Ductal Carcinoma in Situ of the Breast: 12-Year Results From the ECOG-ACRIN E5194 Study. J Clin Oncol. 2015 Nov 20;33(33):3938-44. doi: 10.1200/JCO.2015.60.8588. Epub 2015 Sep 14.
Other Identifiers
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E-5194
Identifier Type: -
Identifier Source: secondary_id
CDR0000065370
Identifier Type: -
Identifier Source: org_study_id
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