Genta has initiated a Phase IIb clinical trial of tesetaxel, its investigational oral taxane, as first-line chemotherapy treatment for women with metastatic breast cancer.
The trial is designed to confirm and extend the safety and efficacy results of Phase Ia trial, which evaluated tesetaxel as second-line treatment of patients with advanced breast cancer.
Its primary endpoint will be percent overall response, while the secondary endpoints include percent progression-free survival at six months, disease control at three months, response duration, time-to-progression and durable response at more than six months.
The study will enrol 25 women with Her2-negative breast cancer. It will be conducted at Memorial Sloan-Kettering Cancer Center and Accelerated Community Oncology Research Network, both in the US.
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