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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 25, 2011

Last Updated Date

January 22, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01483300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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

Study Arm (s)

Experimental: lobaplatin
gemcitabine plus lobaplatin

Intervention: Drug: lobaplatin
Active Comparator: cisplatin
gemcitabine plus cisplatin

Intervention: Drug: cisplatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01483300

Other Study ID Numbers ^ICMJE

BC001

Has Data Monitoring Committee

Yes

Responsible Party

Qingyuan Zhang, Harbin Medical University

Study Sponsor ^ICMJE

Harbin Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Qingyuan Zhang, MD	Cancer Hospital of Harbin Medical University
Principal Investigator:	Xinmei Kang, MD	Cancer Hospital of Harbin Medical University

Information Provided By

Harbin Medical University

Verification Date

January 2012

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

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