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

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ClinicalTrials.gov Identifier: NCT01483300
Recruitment Status : Unknown
Verified January 2012 by Qingyuan Zhang, Harbin Medical University.
Recruitment status was:  Recruiting
First Posted : December 1, 2011
Last Update Posted : January 24, 2012
Sponsor:
Information provided by (Responsible Party):
Qingyuan Zhang, Harbin Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: lobaplatin Drug: cisplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2011
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 4 weeks after chemotherapy ]
    Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)


Secondary Outcome Measures :
  1. Time to progression [ Time Frame: one year after last patient in ]
    Time to progression defined as time from randomization to disease progress.

  2. Overall Survival [ Time Frame: one year after last patient in ]
    Overall survival defined as time from randomization to death from any cause.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483300


Contacts
Contact: Qingyuan Zhang, MD 86-451-86298276 zhma19650210@163.com
Contact: Xinmei Kang, MD 86-451-86298683 kxm791107@163.com

Locations
China, Heilongjiang
Cancer Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Qingyuan Zhang, MD    86-451-86298276    zhma19650210@163.com   
Contact: Xinmei Kang, MD    86-451-86298683    kxm791107@163.com   
Principal Investigator: Qingyuan Zhang, MD         
Sub-Investigator: Xinmei Kang, MD         
Sponsors and Collaborators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Qingyuan Zhang, Vice president of Cancer Hospital of Harbin Medical University, Harbin Medical University
ClinicalTrials.gov Identifier: NCT01483300     History of Changes
Other Study ID Numbers: BC001
First Posted: December 1, 2011    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by Qingyuan Zhang, Harbin Medical University:
breast cancer
gemcitabine
lobaplatin
cisplatin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs