Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Overall response rate [ Time Frame: 4 weeks after chemotherapy ] [ Designated as safety issue: No ]Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
- Time to progression [ Time Frame: one year after last patient in ] [ Designated as safety issue: No ]Time to progression defined as time from randomization to disease progress.
- Overall Survival [ Time Frame: one year after last patient in ] [ Designated as safety issue: No ]Overall survival defined as time from randomization to death from any cause.
- Treatment related toxicity [ Time Frame: 4 weeks after chemotherapy ] [ Designated as safety issue: Yes ]Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
gemcitabine plus lobaplatin
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
Active Comparator: cisplatin
gemcitabine plus cisplatin
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483300
|Contact: Qingyuan Zhang, MDfirstname.lastname@example.org|
|Contact: Xinmei Kang, MDemail@example.com|
|Cancer Hospital of Harbin Medical University||Recruiting|
|Harbin, Heilongjiang, China, 150081|
|Contact: Qingyuan Zhang, MD 86-451-86298276 firstname.lastname@example.org|
|Contact: Xinmei Kang, MD 86-451-86298683 email@example.com|
|Principal Investigator: Qingyuan Zhang, MD|
|Sub-Investigator: Xinmei Kang, MD|
|Study Director:||Qingyuan Zhang, MD||Cancer Hospital of Harbin Medical University|
|Principal Investigator:||Xinmei Kang, MD||Cancer Hospital of Harbin Medical University|