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This study will collect rates of local/regional recurrence in select patients who do not receive radiation treatment after lumpectomy surgery. These women must be postmenopausal; have hormone receptor-positive, Her2-negative tumors; have Oncotype-DX RS less than or equal to 18; and plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at sufficiently low risk of local/regional recurrence that omission of adjuvant radiation might be a reasonable option.
This study's primary aim is to determine rates of recurrence with the innovative approach of considering tumor biology to select patients who may avoid radiation, with restriction of eligibility to women aged 50-69 with hormone-sensitive, Her2-negative tumors with Oncotype-DX RS ≤ 18 who plan to receive endocrine therapy. In this way, this study seeks to collect prospective data supporting the idea that this is a population at low risk of LRR in whom omission of adjuvant radiation is reasonable.
Age
50 - 69 years
Sex
FEMALE
Healthy Volunteers
No
Stanford University
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
Loyola University Medical Center
Maywood, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Harvard University
Cambridge, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Northwell Health
Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
East Carolina University
Greenville, North Carolina, United States
Start Date
May 27, 2015
Primary Completion Date
May 1, 2026
Completion Date
May 1, 2026
Last Updated
October 7, 2025
202
ACTUAL participants
endocrine therapy alone without radiotherapy
OTHER
Lead Sponsor
University of Michigan Rogel Cancer Center
Collaborators
NCT07191730
NCT06312176
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06797635