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

January 22, 2012 updated by: Qingyuan Zhang, Harbin Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Cancer Hospital of Harbin Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qingyuan Zhang, MD
        • Sub-Investigator:
          • Xinmei Kang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: lobaplatin
gemcitabine plus lobaplatin
Drug: lobaplatin
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
ACTIVE_COMPARATOR: cisplatin
gemcitabine plus cisplatin
Drug: cisplatin
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: 4 weeks after chemotherapy
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 Frame: one year after last patient in
Time to progression defined as time from randomization to disease progress.
one year after last patient in
Overall Survival
Time Frame: one year after last patient in
Overall survival defined as time from randomization to death from any cause.
one year after last patient in
Treatment related toxicity
Time Frame: 4 weeks after chemotherapy
Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.
4 weeks after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harbin Medical University

Investigators

  • Study Director: Qingyuan Zhang, MD, Cancer Hospital of Harbin Medical University
  • Principal Investigator: Xinmei Kang, MD, Cancer Hospital of Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ANTICIPATED)

August 1, 2014

Study Completion (ANTICIPATED)

November 1, 2014

Study Registration Dates

First Submitted

November 25, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (ESTIMATE)

December 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 22, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe