A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Docetaxel will be given until progression or patient intolerance
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGProgression-free survival(PFS)
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Overall survival(OS)
The time elapsed between enrolling and death from any cause
Time frame: From date of enrolling until the date of death from any cause, assessed up to 5 years
Clinical benefit rate(CBR)
The response is CR+PR+SD ≥ 24 weeks
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Quality of life（QOL）
Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Number of participants with Grade 3/4 adverse events
Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.
Time frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
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