Eribulin Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)
A Phase II, Single-center, Randomized Study of Eribulin Plus Cisplatin (EP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Eribulin 1.4mg/m2, IV , D1, D8;Cisplatin 75 mg/m2, IV,D1
Gemcitabine 1250 mg/m2, IV , D1, D8; Cisplatin 75 mg/m2, IV, D1
Fudan University Shanghai Cancer center
Shanghai, China
PFS
Progression Free Survival
Time frame: approximately 6 weeks
ORR
Objective Response Rate
Time frame: approximately 6 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: approximately 18 weeks
OS
Overall Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
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