NCT05670054

Cyclin Dependant Kinase 4/6 (CDK4/6) Inhibitors as a Second Line Treatment in Metastatic Breast Cancer Patients

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients.

Detailed description

Breast cancer is the commonest malignancy among females and one of the leading causes of death worldwide. Many drugs have been developed over the years to try to extend survival among these patients including cyclin dependant kinase inhibitors. Cyclin dependant kinase inhibitors (CDK inhibitors) mainly Palbociclib (PAL), ribociclib (RIB) and abemaciclib (ABM) are approved for treatment of hormone receptor positive, HER2 negative advanced breast cancer in the 1st line and subsequent lines in combination with aromatase inhibitors or fulvestrant. Studies showed that they extend progression free survival and recently they showed overall survival benefit. In this study investigators compare Palbociclib+ fulvestrant VS Ribociclib + fulvestrant as a second line treatment in metastatic ER+ve her2 -ve BC in oncology center mansoura university egyptian patients. The efficacy and comparative toxicity of CDK inhibitors were indirectly compared in a number of trials. Despite differences in inclusion criteria and follow-up length, second-line trials showed similar characteristics. Unfortunately, despite the similar efficacy and overall response rate (ORR) and a slightly different but near-identical spectrum of adverse events, both agents have not been directly compared with each other. This study aims to fill that gap, and evaluate the toxicity, tolerability and response rate of ribociclib plus fulvestrant versus palbociclib plus fulvestrant, to inform the decision makers.

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival	comparing both arms as regard the objective response rate, toxicity profile, quality of life, progression free survival

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-10-15
• Completion: 2023-12-15
• First posted: 2023-01-04
• Last updated: 2023-01-04

Locations

1 site across 1 country: Egypt