A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer with RS<25 (RxFINE-Low)
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC), FPBCC CTO Studies
Current Status: Open
Phase: III
Principal Investigator: Elder, Simran
Contact Information:
Brandy Bach
brbach@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07391774?term=NCT07391774&viewType=Card&rank=1#participation-criteria
Summary
PRIMARY OBJECTIVE:
I. To determine whether optimal adjuvant endocrine therapy with CDK4/6 inhibitor is non-inferior to adjuvant chemotherapy followed by optimal endocrine therapy with CDK4/6 inhibitor as evaluated by invasive breast cancer-free survival (iBCFS).
SECONDARY OBJECTIVES:
I. To compare 5-year invasive disease-free survival (iDFS), distant disease-free survival (DDFS), distant recurrence-free survival (DRFS), recurrence-free interval (RFI), overall survival (OS), and breast cancer-specific survival (BCSS) in patients who receive adjuvant chemotherapy versus patients who do not.
II. To compare the short-term and long-term toxicity profiles of each arm.
EXPLORATORY OBJECTIVE:
I. To create a biorepository of tumor tissue and peripheral blood biospecimens for future research.