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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
lobaplatin
cisplatin
Sponsored by
Harbin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, gemcitabine, lobaplatin, cisplatin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital of Harbin Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

lobaplatin

cisplatin

Arm Description

gemcitabine plus lobaplatin

gemcitabine plus cisplatin

Outcomes

Primary Outcome Measures

Overall response rate
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)

Secondary Outcome Measures

Time to progression
Time to progression defined as time from randomization to disease progress.
Overall Survival
Overall survival defined as time from randomization to death from any cause.
Treatment related toxicity
Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.

Full Information

First Posted
November 25, 2011
Last Updated
January 22, 2012
Sponsor
Harbin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01483300
Brief Title
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harbin Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, gemcitabine, lobaplatin, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lobaplatin
Arm Type
Experimental
Arm Description
gemcitabine plus lobaplatin
Arm Title
cisplatin
Arm Type
Active Comparator
Arm Description
gemcitabine plus cisplatin
Intervention Type
Drug
Intervention Name(s)
lobaplatin
Intervention Description
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
Primary Outcome Measure Information:
Title
Overall response rate
Description
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
Time Frame
4 weeks after chemotherapy
Secondary Outcome Measure Information:
Title
Time to progression
Description
Time to progression defined as time from randomization to disease progress.
Time Frame
one year after last patient in
Title
Overall Survival
Description
Overall survival defined as time from randomization to death from any cause.
Time Frame
one year after last patient in
Title
Treatment related toxicity
Description
Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.
Time Frame
4 weeks after chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingyuan Zhang, MD
Phone
86-451-86298276
Email
zhma19650210@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinmei Kang, MD
Phone
86-451-86298683
Email
kxm791107@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, MD
Organizational Affiliation
Cancer Hospital of Harbin Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xinmei Kang, MD
Organizational Affiliation
Cancer Hospital of Harbin Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, MD
Phone
86-451-86298276
Email
zhma19650210@163.com
First Name & Middle Initial & Last Name & Degree
Xinmei Kang, MD
Phone
86-451-86298683
Email
kxm791107@163.com
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang, MD
First Name & Middle Initial & Last Name & Degree
Xinmei Kang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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