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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.
Stanford University
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
Loyola University Medical Center
Maywood, Illinois, United States
Loco-regional Recurrence
All patients will be followed for their clinical outcome for at least 10 years, specifically: for development of recurrence (and site), the salvage therapy type if local disease recurs, for development of distant metastasis, and survival - both overall and breast-cancer specific.
Time frame: 5 years of follow up
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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
...and 3 more locations