Phase 2
18 Years
70 Years
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall response rate
Outcome Description:
Overall response rate (ORR) defined as complete response(CR) + partial response(PR) + stable disease (SD)
Outcome Time Frame:
4 weeks after chemotherapy
Safety Issue:
No
Principal Investigator
Qingyuan Zhang, MD
Investigator Role:
Study Director
Investigator Affiliation:
Cancer Hospital of Harbin Medical University
Authority:
China: Ethics Committee
Study ID:
BC001
NCT ID:
NCT01483300
Start Date:
November 2011
Completion Date:
November 2014
Related Keywords:
- Breast Cancer
- breast cancer
- gemcitabine
- lobaplatin
- cisplatin
- Breast Neoplasms
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