Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: lobaplatin
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lobaplatin<br>gemcitabine plus lobaplatin | Drug: lobaplatin<br>* Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks<br>|
| Active Comparator: cisplatin<br>gemcitabine plus cisplatin | Drug: cisplatin<br>* Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, gemcitabine, lobaplatin, cisplatin