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Fig. 1 | Trials

Fig. 1

From: Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial

Fig. 1

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Timepoint (t): -t1: baseline evaluations (conducted within 2 weeks of the start of protocol therapy); t0: random allocation; t1: during treatment (evaluations will be conducted every 6 weeks (two cycles)); t2: patients will be monitored for new or existing AEs at 4 weeks after treatment discontinuation; t3: follow up for survival will be monitored every 3 months after treatment discontinuation until patient death or study completion. *Eligible patients will be randomly assigned to receive either oral vinorelbine plus placebo (control group) or oral vinorelbine combined with apatinib mesylate (experimental group). a Concomitant medication includes opioid analgesics and new anticancer treatment. b Laboratory examinations include hematology (hemoglobin, white blood cell count, neutrophil count, and platelet count); blood biochemical tests (total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, serum creatinine, total protein, Na+, K+, Mg2+, Cl−, Ca2+, urea, and pregnancy test (if applicable); and tumor marker detection (breast cancer-associated antigen CA153 and carcinoembryonic antigen). ECOG PS, Eastern Cooperative Oncology Group performance status; EORTC QLQ-C30, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30

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