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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Qingyuan Zhang, Harbin Medical University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Qingyuan Zhang, Harbin Medical University Identifier:
First received: November 25, 2011
Last updated: January 22, 2012
Last verified: January 2012
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 Intervention Phase
Breast Cancer
Drug: lobaplatin
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Qingyuan Zhang, Harbin Medical University:

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

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

  • 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.

Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT01483300

Contact: Qingyuan Zhang, MD 86-451-86298276
Contact: Xinmei Kang, MD 86-451-86298683

China, Heilongjiang
Cancer Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150081
Contact: Qingyuan Zhang, MD    86-451-86298276   
Contact: Xinmei Kang, MD    86-451-86298683   
Principal Investigator: Qingyuan Zhang, MD         
Sub-Investigator: Xinmei Kang, MD         
Sponsors and Collaborators
Harbin Medical University
Study Director: Qingyuan Zhang, MD Cancer Hospital of Harbin Medical University
Principal Investigator: Xinmei Kang, MD Cancer Hospital of Harbin Medical University
  More Information

Responsible Party: Qingyuan Zhang, Vice president of Cancer Hospital of Harbin Medical University, Harbin Medical University Identifier: NCT01483300     History of Changes
Other Study ID Numbers: BC001
Study First Received: November 25, 2011
Last Updated: January 22, 2012

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017