A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Brief description of study

Primary Objective: To estimate subsequent recurrence-free survival (RFS) at 3 years for ribociclib when administered with ET (AIs or fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC). Secondary Objectives: To estimate distant metastasis-free survival To estimate overall survival (OS). To evaluate safety and tolerability To identify predictors of loco-regional recurrence.


Clinical Study Identifier: s22-00921
ClinicalTrials.gov Identifier: NCT05467891
Principal Investigator: Nancy Chan.
Other Investigators: Caitlin Elizabeth Ordonez Ferri, Barbara E Stelzer, Akilah Monique Bryant, Elizabeth Comen, Danielle Seidman, Natalie Jill Klar, Annmarie Johnson-Rowe, Yelena Novik, Marleen I Meyers, Neil Vasan, Maryann J Kwa, Shridar Ganesan, Douglas K Marks, Amanda Marie Buzolich, Gregory Edward Totero, Anastasiya Apanasyuk, Ruth Oratz, Stacy Antwi, Naomi Yu Ko, Wanqing Iris Zhi, Chrystal Teran, Eliana Ferreira, Alexander A Hindenburg.


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