drugset / Trial / NCT04047758

Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer

NCT04047758

Phase 3 Unknown 420 enrolled Shengjing Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018. Palbociclib combined with an aromatase inhibitor can be used to treat hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer or metastatic breast cancer. This brings more treatment options for hormone receptor-positive/human epidermal growth factor receptor 2-negative locally advanced breast cancer. How to scientifically evaluate the efficacy, tolerability, and safety of palbociclib combined with an aromatase inhibitor and to establish a more suitable treatment strategy for Chinese patients is one of the questions that need to be answered in clinical practice. This multi-center parallel-group randomized controlled trial will address on this issue.

Timeline

Start
2019-09-01
Primary completion
2021-09-30
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Palbociclib Small molecule 125 mg Oral
Comparator Letrozole Other / unclassified 2.5 mg Oral

Indications