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Trial Title:
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
NCT ID:
NCT01483300
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Cisplatin
Conditions: Keywords:
breast cancer
gemcitabine
lobaplatin
cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
lobaplatin
Description:
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
Arm group label:
lobaplatin
Intervention type:
Drug
Intervention name:
cisplatin
Description:
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
Arm group label:
cisplatin
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed metastatic breast cancer
- Disease progression during or after previous 1st line chemotherapy
- Scheduled to receive 2nd line chemotherapy.
- Measurable disease, defined as a least one lesion that can be accurately measured in
at least one dimension
- 18 years of age or older
- ECOG performance status of 0-2
- Life expectancy of greater than 6 months
Exclusion Criteria:
- Previous treatment with one of the study drugs
- Application of other cytotoxic chemotherapy or radiotherapy
- Insufficent renal function (creatinine clearance < 60ml/min)
- Clinically unstable brain metastasis
- Pregancy or lactation
- History of other malignancy within last 5 years.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang, MD
Phone:
86-451-86298276
Email:
zhma19650210@163.com
Contact backup:
Last name:
Xinmei Kang, MD
Phone:
86-451-86298683
Email:
kxm791107@163.com
Investigator:
Last name:
Qingyuan Zhang, MD
Email:
Principal Investigator
Investigator:
Last name:
Xinmei Kang, MD
Email:
Sub-Investigator
Start date:
November 2011
Completion date:
November 2014
Lead sponsor:
Agency:
Harbin Medical University
Agency class:
Other
Source:
Harbin Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01483300
