Breast Cancer
Conditions
Keywords
breast cancer, gemcitabine, lobaplatin, cisplatin
Brief 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.
Interventions
DRUGlobaplatin
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
DRUGcisplatin
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
Sponsors
Harbin Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 4 weeks after chemotherapy | Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | one year after last patient in | Time to progression defined as time from randomization to disease progress. |
| Overall Survival | one year after last patient in | Overall survival defined as time from randomization to death from any cause. |
| Treatment related toxicity | 4 weeks after chemotherapy | Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system. |
Countries
China
Contacts
Primary ContactQingyuan Zhang, MD
Backup ContactXinmei Kang, MD
Outcome results
None listed