drugset / Trial / NCT03949634
Cardiac Safety and Efficacy for Early-stage Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin(PLD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |