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

• Status: Unknown status
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Harbin Medical University
• Treatments: Cisplatin; Gemcitabine

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.