Study Stopped
This study was terminated when the accrual goal for the low/intermediate grade stratum was reached. The high grade stratum was closed due to slow accrual.
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
3 other identifiers
interventional
711
2 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jun 1997
Longer than P75 for phase_2 breast-cancer
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 25, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
April 16, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedJune 22, 2023
June 1, 2023
10.4 years
November 1, 1999
June 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Actuarial local recurrence rate
Rate of in situ or invasive local breast cancer recurrence
Assessed at 5 years
Study Arms (1)
Pathology Review, Observation and Follow-up
NO INTERVENTIONPathology review, observation and follow-up
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (30)
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033, United States
CCOP - Evanston
Evanston, Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, 46202, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
New England Medical Center Hospital
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065, United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295, United States
Pretoria Academic Hospitals
Pretoria, 0001, South Africa
Related Publications (3)
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.
PMID: 19826126RESULTHughes 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.
RESULTSolin 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.
PMID: 26371148DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lorie L. Hughes, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 1999
First Posted
April 16, 2003
Study Start
June 25, 1997
Primary Completion
December 1, 2007
Study Completion
October 1, 2012
Last Updated
June 22, 2023
Record last verified: 2023-06