Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- lobaplatin
- Conditions
- Breast Cancer
- Sponsor
- Harbin Medical University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Overall response rate
- Last Updated
- 14 years ago
Overview
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.
Investigators
Qingyuan Zhang
Vice president of Cancer Hospital of Harbin Medical University
Harbin Medical University
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.
Arms & Interventions
lobaplatin
gemcitabine plus lobaplatin
Intervention: lobaplatin
cisplatin
gemcitabine plus cisplatin
Intervention: cisplatin
Outcomes
Primary Outcomes
Overall response rate
Time Frame: 4 weeks after chemotherapy
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
Secondary Outcomes
- Time to progression(one year after last patient in)
- Overall Survival(one year after last patient in)
- Treatment related toxicity(4 weeks after chemotherapy)