This study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy ER+/HER2- recurrent metastatic breast cancer。
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
108
nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity. According to the calculation results, the administered dose can be within ± 10% of the calculated dose.
Objective Response Rate (ORR)
Defined as proportion of complete response and partial response according to RECIST 1.1 criteria.
Time frame: Estimated up to 1 year
Clinical benefit rate
Defined as proportion of complete response 、partial response and stable disease according to RECIST 1.1 criteria.
Time frame: CR+PR+SD≥8 weeks
Progression-Free Survival (PFS)
Calculated from the time the study drug was first administered to the first confirmation of disease progression or death (whichever occurs first)
Time frame: Estimated up to 2 year
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