An Open-label, Single-arm, Multicenter, Phase II Study to Assess the Efficacy and Safety of Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule) as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer
Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the
5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has
reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic
breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced
breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of
gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study
data of TS-1 in breast cancer so far.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Up to 2 years
No
Binghe Xu, MD, PhD
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
China: Food and Drug Administration
CH-BC-014
NCT01492543
December 2011
October 2014
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