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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)
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.
Exploratory Objectives:
To explore prognostic and predictive biomarkers of treatment with ribociclib and ET.
To explore potential molecular mechanisms of resistance to study treatment.
To explore the correlation of molecular landscape of recurrence with clinical endpoints (e.g., PIK3CA mutations, ESR1 mutations).
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.
Exploratory Objectives:
To explore prognostic and predictive biomarkers of treatment with ribociclib and ET.
To explore potential molecular mechanisms of resistance to study treatment.
To explore the correlation of molecular landscape of recurrence with clinical endpoints (e.g., PIK3CA mutations, ESR1 mutations).
Recruitment Status
Suspended