A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Wahl, Andrew
Eligibility: https://clinicaltrials.gov/ct2/show/NCT04852887?term=NCT04852887&draw=2&rank=1#eligibility
Summary
1.1 Primary Objective
To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
1.2 Secondary Objectives
1.2.1 To evaluate whether breast conservation surgery and endocrine therapy inclusive of any second breast conservation surgery for salvage of IBTR results in a non-inferior rate of overall breast conservation compared to breast conserving surgery, endocrine therapy and radiation for IBTR.
1.2.2 To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive ipsilateral breast tumor recurrence (IIBTR) compared to breast conservation, breast radiation, and endocrine therapy.
1.2.3 To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior relapse free interval (RFI) compared to breast conservation, breast radiation, and endocrine therapy.
1.2.4 To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior distant disease-free survival(DDFS) compared to breast conservation, breast radiation, and endocrine therapy.
1.2.5 To evaluate whether breast conservation surgery and endocrine therapy results in a non-inferior overall survival (OS) compared to breast conservation, breast radiation, and endocrine therapy.
1.2.6 To evaluate whether there is a difference in patient-reported breast pain in women who do and do not receive breast radiation.
1.2.7 To evaluate whether there is a difference in patient-reported worry about recurrence in women who do and do not receive breast radiation.
1.2.8 To evaluate whether adherence to endocrine therapy following breast conservation surgery alone is non inferior compared to endocrine therapy with breast conservation surgery and breast radiation.