drugset / Trial / NCT03949634

Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin(PLD)

NCT03949634 ↗

Phase 3 Unknown 272 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, multicenter, open, controlled Post-Marketing Study. 272 early stage female breast cancer patients who were histopathology confirmed with adjuvant chemotherapy indications were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by trastuzumab,age,baseline cardiac risk factors.

Timeline

Start
2017-09-01
Primary completion
2019-10-31
Completion
2020-10-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject Pegylated liposomal doxorubicin Unknown 35 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Docetaxel Small molecule 100 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous