Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01483300|
Recruitment Status : Unknown
Verified January 2012 by Qingyuan Zhang, Harbin Medical University.
Recruitment status was: Recruiting
First Posted : December 1, 2011
Last Update Posted : January 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: lobaplatin Drug: cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||November 2014|
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
- Overall response rate [ Time Frame: 4 weeks after chemotherapy ]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 ]Time to progression defined as time from randomization to disease progress.
- Overall Survival [ Time Frame: one year after last patient in ]Overall survival defined as time from randomization to death from any cause.
- Treatment related toxicity [ Time Frame: 4 weeks after chemotherapy ]Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483300
|Contact: Qingyuan Zhang, MDemail@example.com|
|Contact: Xinmei Kang, MDfirstname.lastname@example.org|
|Cancer Hospital of Harbin Medical University||Recruiting|
|Harbin, Heilongjiang, China, 150081|
|Contact: Qingyuan Zhang, MD 86-451-86298276 email@example.com|
|Contact: Xinmei Kang, MD 86-451-86298683 firstname.lastname@example.org|
|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|