drugset / Trial / NCT01483300

Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer

NCT01483300

Phase 2 Unknown 80 enrolled Harbin Medical University
RandomizedParallel-groupOpen-labelTreatment

Summary

Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.

Timeline

Start
2011-11
Primary completion
2014-08
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cisplatin Other / unclassified 25 mg/m2
Subject Lobaplatin Small molecule 30 mg/m2
Background Gemcitabine Small molecule 1000 mg/m2

Indications