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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: lobaplatin; Drug: cisplatin

• Registration Number: NCT01483300
• Lead Sponsor: Harbin Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-25
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-12-01
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-22
• Last Update Posted: 2012-01-24
• Primary Completion: 2014-08
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lobaplatin	lobaplatin	gemcitabine plus lobaplatin
cisplatin	cisplatin	gemcitabine plus cisplatin

Primary Outcome Measures

Name	Time	Method
Overall response rate	4 weeks after chemotherapy	Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cancer Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China