drugset / Trial / NCT05670054

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

NCT05670054

Phase 3 Unknown 116 enrolled Mansoura University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-03-01
Primary completion
2023-10-15
Completion
2023-12-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Palbociclib Small molecule 125 mg Oral
Comparator Ribociclib Small molecule 200 mg Oral
Comparator Fulvestrant Small molecule 500 mg Intramuscular