Table 3.

Phase II and Phase III clinical studies of Utidelone for advanced metastatic breast cancer.

Researchers	Study Subjects	Interventions	Findings	Safety
Pin Zhang et al[10]	18–70 yr of age with advanced metastatic breast cancer; prior chemotherapy regimen including anthracycline-containing and/or paclitaxel-based regimens	33 patients were included in the combination group with utidelone in combined with capecitabine; 63 patients were included in the monotherapy group (utidelone)	ORR of 42.4% and median PFS of 7.9 mo in the combination treatment group; ORR of 28.57% and median PFS of 5.4 mo in the monotherapy group	Common toxicity is peripheral neuropathy and fatigue, with limited and controllable toxicity
Pin Zhang et al[11] Xu B. et al[12]	Patients with metastatic breast cancer resistant to anthracycline and paclitaxel-based chemotherapy regimens	270 subjects were included in the utidelone combined with capecitabine group; 135 were included in the capecitabine monotherapy group	The median PFS was 8.44 mo (95% CI 7.95–9.92) in the combination therapy group and 4.55 mo (95% CI 2.55–9.39) in the monotherapy group. The median OS was 19.8 mo in the combination therapy group compared with 16.0 mo in the monotherapy group [(HR) = 0.75, 95% CI 0.59–0.94, P = .0142	Common toxicity is peripheral neuropathy