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

This study is currently recruiting participants.
Verified January 2012 by Harbin Medical University
Sponsor:
Information provided by (Responsible Party):
Qingyuan Zhang, Harbin Medical University
ClinicalTrials.gov Identifier:
NCT01483300
First received: November 25, 2011
Last updated: January 22, 2012
Last verified: January 2012

November 25, 2011
January 22, 2012
November 2011
August 2014   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 4 weeks after chemotherapy ] [ Designated as safety issue: No ]
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
Same as current
Complete list of historical versions of study NCT01483300 on ClinicalTrials.gov Archive Site
  • Time to progression [ Time Frame: one year after last patient in ] [ Designated as safety issue: No ]
    Time to progression defined as time from randomization to disease progress.
  • Overall Survival [ Time Frame: one year after last patient in ] [ Designated as safety issue: No ]
    Overall survival defined as time from randomization to death from any cause.
  • Treatment related toxicity [ Time Frame: 4 weeks after chemotherapy ] [ Designated as safety issue: Yes ]
    Treatment related toxicities will be recorded as chemotherapy toxicity grades in hematologic, renal, hepatic and gastrointestinal system.
Same as current
Not Provided
Not Provided
 
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • Experimental: lobaplatin
    gemcitabine plus lobaplatin
    Intervention: Drug: lobaplatin
  • Active Comparator: cisplatin
    gemcitabine plus cisplatin
    Intervention: Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
November 2014
August 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact: Qingyuan Zhang, MD 86-451-86298276 zhma19650210@163.com
Contact: Xinmei Kang, MD 86-451-86298683 kxm791107@163.com
China
 
NCT01483300
BC001
Yes
Qingyuan Zhang, Harbin Medical University
Harbin Medical University
Not Provided
Study Director: Qingyuan Zhang, MD Cancer Hospital of Harbin Medical University
Principal Investigator: Xinmei Kang, MD Cancer Hospital of Harbin Medical University
Harbin Medical University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP