- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483300
Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
January 22, 2012 updated by: Qingyuan Zhang, Harbin Medical University
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qingyuan Zhang, MD
- Phone Number: 86-451-86298276
- Email: zhma19650210@163.com
Study Contact Backup
- Name: Xinmei Kang, MD
- Phone Number: 86-451-86298683
- Email: kxm791107@163.com
Study Locations
-
-
Heilongjiang
-
Harbin, Heilongjiang, China, 150081
- Recruiting
- Cancer Hospital of Harbin Medical University
-
Contact:
- Qingyuan Zhang, MD
- Phone Number: 86-451-86298276
- Email: zhma19650210@163.com
-
Contact:
- Xinmei Kang, MD
- Phone Number: 86-451-86298683
- Email: kxm791107@163.com
-
Principal Investigator:
- Qingyuan Zhang, MD
-
Sub-Investigator:
- Xinmei Kang, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: lobaplatin
gemcitabine plus lobaplatin
|
Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
|
ACTIVE_COMPARATOR: cisplatin
gemcitabine plus cisplatin
|
Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: 4 weeks after chemotherapy
|
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
|
4 weeks after chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to progression
Time Frame: one year after last patient in
|
Time to progression defined as time from randomization to disease progress.
|
one year after last patient in
|
Overall Survival
Time Frame: one year after last patient in
|
Overall survival defined as time from randomization to death from any cause.
|
one year after last patient in
|
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.
|
4 weeks after chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Qingyuan Zhang, MD, Cancer Hospital of Harbin Medical University
- Principal Investigator: Xinmei Kang, MD, Cancer Hospital of Harbin Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ANTICIPATED)
August 1, 2014
Study Completion (ANTICIPATED)
November 1, 2014
Study Registration Dates
First Submitted
November 25, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (ESTIMATE)
December 1, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 24, 2012
Last Update Submitted That Met QC Criteria
January 22, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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