NCT01483300

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	lobaplatin	Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
DRUG	cisplatin	Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2011-12-01
• Last updated: 2012-01-24

Locations

1 site across 1 country: China