The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
Metronomic chemotherapy has been considered as an effective strategy for metastatic breast cancer. This trial is designed to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
Docetaxel 75mg/m2 IVGTT D1;every 21days
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProgression Free Survival
Time frame: 6 weeks
Biomarker serum VEGF level
Relationship of serum VEGF level and efficacy
Time frame: 6 weeks
Biomarker immuno-marker
Relationship of immuno-marker(CD3,CD4,CD8 ect) and efficacy
Time frame: 6 weeks
Efficacy Overall Response Rate
Overall Response Rate
Time frame: 6 weeks
Efficacy Overall Survival
Overall Survival, OS
Time frame: 6 weeks
Safety
Safety(NCI CTCAE v4.0)
Time frame: 6 weeks
genetic polymorphisms
To evaluate the relationship of genetic polymorphisms and efficacy.
Time frame: 6 weeks
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