- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002934
Evaluation of Breast Cancer Recurrence Rates Following Surgery in Women With Ductal Carcinoma In Situ
Local Excision Alone for Selected Patients With DCIS of the Breast
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pretoria, South Africa, 0001
- Pretoria Academic Hospitals
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Decatur, Georgia, United States, 30033
- Veterans Affairs Medical Center - Atlanta (Decatur)
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Illinois
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Evanston, Illinois, United States, 60201
- CCOP - Evanston
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Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Indianapolis, Indiana, United States, 46202
- Veterans Affairs Medical Center - Indianapolis (Roudebush)
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Iowa
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Cedar Rapids, Iowa, United States, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
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Kansas
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Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02111
- New England Medical Center Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Ann Arbor Regional
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Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
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Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
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New Jersey
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Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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Ohio
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Cleveland, Ohio, United States, 44106-5065
- Ireland Cancer Center
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Oklahoma
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Tulsa, Oklahoma, United States, 74136
- CCOP - Oklahoma
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania Cancer Center
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Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37212
- Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- CCOP - Green Bay
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Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Medical Research and Education Foundation
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Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, United States, 53295
- Veterans Affairs Medical Center - Milwaukee (Zablocki)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Pathology Review, Observation and Follow-up
Pathology review, observation and follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actuarial local recurrence rate
Time Frame: Assessed at 5 years
|
Rate of in situ or invasive local breast cancer recurrence
|
Assessed at 5 years
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Lorie L. Hughes, MD, Emory University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000065370
- U10CA021115 (U.S. NIH Grant/Contract)
- E-5194
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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