It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
Cancer Institute and Hospital, Chinese Academy Of Medical Sciences
Beijing, China
RECRUITINGProgression Free Survival (PFS)
Time from randomization to progression or death (whichever occurred first).
Time frame: up to 36 months
Adverse events (AEs)
Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0), premature withdrawals and vital signs. Hand-foot syndrome and diarrhea will be specially interested. Adverse events of special interest: hand-foot syndrome and diarrhea. The estimated HFS rate will be about 60% from intermittent Capecitabine vs about 10% from metronomic Capecitabine, diarrhea rate will be about 50% from intermittent Capecitabine vs about 10% from metronomic Capecitabine.
Time frame: up to 36 months
Overall survival (OS):
Time from randomization to death
Time frame: up to 52 months
Overall Response rates (ORR)
Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase.
Time frame: up to 36 months
Clinical Benefit rate (CBR)
Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase
Time frame: up to 36 months
Time to Progression (TTP)
Time from randomization to disease progression
Time frame: up to 36 months
QoL
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Using the EORTC quality of life questionnaire QLQ-C30
Time frame: up to 36 months