Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype (HARMONIA)
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: Asif, Samia
Contact Information:
Krista Patterson
kpatterson@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05207709?term=NCT05207709&draw=2&rank=1#eligibility
Summary
Primary Objective
To compare PFS of ribociclib plus endocrine therapy over palbociclib plus endocrine therapy with respect to PFS in patients with advanced hormone receptor-positive, HER2-negative and HER2-E breast cancer.
Secondary Objectives
To compare the two treatment arms with respect to PFS2 in the HER2-E cohort
To compare the two treatment arms with respect to overall survival in the HER2-E cohort
To evaluate the two treatment arms with respect to ORR and clinical benefit rate (CBR) in HER2-E patients, where CBR, defined as percentage of patients with CR, PR per RECIST 1.1 or SD lasting 24 weeks or longer.
To describe time to response and duration of response in each treatment arm.
To evaluate the safety and tolerability of ribociclib and palbociclib in combination with endocrine therapy the HER2-E cohort
To evaluate patient reported outcomes for health-related quality of life in the two treatment arms of the HER2-E cohort.
Exploratory Objectives
To describe the PFS in patients with the Basal-like subtype treated with paclitaxel
To describe the overall survival in patients with the Basal-like subtype treated with paclitaxel
To describe ORR and CBR in patients with the Basal-like subtype treated with paclitaxel, where CBR is defined as percentage of patients with CR, PR per RECIST or SD lasting 24 weeks or longer
Exploratory Translational Objectives
To explore molecular alterations in circulating tumor DNA (ctDNA)
To assess the drop of ctDNA after 4 weeks as a potential efficacy marker
To identify potential molecular marker of resistance (Tumor and/or CtDNA) for patient failing to benefit from CDK4/6 treatment in HER2-E tumors and paclitaxel in basal-like tumors
To assess the correlation between molecular alterations detected at baseline in circulating tumor DNA (ctDNA) by NGS and tumor tissues
To compare subtype in primary vs metastatic paired samples.