drugset / Trial / NCT03785704

Clinical Study of Xinmailong Injection on Reducing Cardiovascular Toxicity in Adjuvant Chemotherapy in Breast Cancer

NCT03785704 ↗

Phase 2 Unknown 60 enrolled Peking Union Medical College
RandomizedParallel-groupOpen-labelTreatment

Summary

Totally 60 subjects will be included in the study. The present study was aimed to observe and evaluate the effect of Xinmailong injection on reducing cardiovascular toxicity associated with adjuvant chemotherapy after breast cancer surgery. The primary endpoint was 6 months of cardiac safety. Secondary endpoints included 3 months of cardiac safety, adverse events (AE), severe adverse events (SAE), and DFS.

Timeline

Start
2019-01-01
Primary completion
2020-03-01
Completion
2025-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Xinmailong Injection Peptide 5 mg/kg —