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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 25, 2011
Last Updated: January 22, 2012
Health Authority: China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014