Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR)
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)
-
Clinical Trial Information
Trial Contact: Ribacchi, Stephanie; Durand, Jennifer
Trial Phone: 321-841-1077 ; 321.843.2026
-
IRB No: 20226221
Protocol Abbrev: HCRN BRE20-468
Principal Investigator: Ana Elisa Cuesta Fernandez, MD
Phase: Drug: Phase II
Age Group: Adult
Treatment: Drug: Ribociclib 600 mg orally once daily Days 1-21 (28 day Cycle) Other Name: Kisqali Drug: Fulvestrant 500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+ Other Name: Faslodex Drug: Anastrozole 1 mg orally once daily Other Name: Arimidex Drug: Letrozole 2.5 mg orally once daily Other Name: Femara Drug: Exemestane 25 mg orally once daily Other Name: Aromasin
ClinicalTrials.gov ID: NCT05467891
-
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). -
Key Eligibility
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).
