64
Participants
Start Date
January 31, 2022
Primary Completion Date
March 31, 2028
Study Completion Date
March 31, 2029
Trastuzumab Deruxtecan (T-DXd) monotherapy
T-DXd will be administered at a dose of 6.4 mg/kg (decimal) by intravenous infusion every 21 days (3 weeks) for subsequent three cycles.
T-DXd, Durvalumab and Capecitabine Combination
Administer each cycle over 21 days. T-DXd is administered by intravenous infusion at 5.4 mg/kg every 21 days (every 3 weeks). Capecitabine is given at 750 mg/m2 BID, taken orally for 14 days, followed by a drug holiday from the evening of Day 15 to the morning of Day 22 (Day 1 of the next cycle). Durvalumab is administered at 1500 mg by intravenous infusion over 60 minutes every 21 days (every 3 weeks). As neoadjuvant chemotherapy, administer T-DXd, Capecitabine, and Durvalumab in combination on a q3w schedule for 3 cycles. As adjuvant chemotherapy consists of T-DXd, Capecitabine, and Durvalumab in combination on a q3w schedule for 3 cycles, followed by Durvalumab monotherapy on a q4w schedule until 10 cycles are completed.
RECRUITING
National Cancer Center Hospital East, Kashiwa
Collaborators (1)
Daiichi Sankyo Co., Ltd.
INDUSTRY
National Cancer Center Hospital East
OTHER