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 because the information has not been verified recently.

Verified January 2012 by Harbin Medical University.
Recruitment status was Recruiting

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

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cisplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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 March 01, 2015

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