Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT01483300 |
Recruitment Status
: Unknown
Verified January 2012 by Qingyuan Zhang, Harbin Medical University.
Recruitment status was: Recruiting
First Posted
: December 1, 2011
Last Update Posted
: January 24, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: lobaplatin Drug: cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
---|---|
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
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- Overall response rate [ Time Frame: 4 weeks after chemotherapy ]Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
- 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.

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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483300
Contact: Qingyuan Zhang, MD | 86-451-86298276 | zhma19650210@163.com | |
Contact: Xinmei Kang, MD | 86-451-86298683 | kxm791107@163.com |
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 |
Study Director: | Qingyuan Zhang, MD | Cancer Hospital of Harbin Medical University | |
Principal Investigator: | Xinmei Kang, MD | Cancer Hospital of Harbin Medical University |
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 |
First Posted: | December 1, 2011 Key Record Dates |
Last Update Posted: | January 24, 2012 |
Last Verified: | January 2012 |
Keywords provided by Qingyuan Zhang, Harbin Medical University:
breast cancer gemcitabine lobaplatin cisplatin |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Cisplatin Antineoplastic Agents Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |