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

NCT01483300 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-01-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

lobaplatin

Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks

DRUG

cisplatin

Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Principal Investigators

  • Qingyuan Zhang, MD · Cancer Hospital of Harbin Medical University

  • Xinmei Kang, MD · Cancer Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-08-31
Completion
2014-11-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01483300 on ClinicalTrials.gov