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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lobaplatin | Experimental | gemcitabine plus lobaplatin |
|
| cisplatin | Active Comparator | gemcitabine plus cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lobaplatin | Drug | Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD) | 4 weeks after chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | Time to progression defined as time from randomization to disease progress. | one year after last patient in |
| Overall Survival | Overall survival defined as time from randomization to death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyuan Zhang, MD | Contact | 86-451-86298276 | zhma19650210@163.com | |
| Xinmei Kang, MD | Contact | 86-451-86298683 | kxm791107@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qingyuan Zhang, MD | Cancer Hospital of Harbin Medical University | Study Director |
| Xinmei Kang, MD | Cancer Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C066228 | lobaplatin |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| cisplatin |
| Drug |
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks |
|
| one year after last patient in |
| Treatment related toxicity | Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system. | 4 weeks after chemotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |