drugset / Trial / NCT02630693

Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer

NCT02630693

Phase 2 Completed 180 enrolled Canadian Cancer Trials Group Pfizer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.

Timeline

Start
2016-04-08
Primary completion
2018-08-15
Completion
2023-11-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Palbociclib Small molecule 100 mg Oral
Comparator Palbociclib Small molecule 125 mg Oral
Comparator Fulvestrant Small molecule
Comparator Tamoxifen Small molecule

Indications