SKB264 Injection Vs Investigator Selected Regimens to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

June 10, 2022

Primary Completion Date

November 30, 2023

Study Completion Date

March 31, 2025

Conditions
Triple Negative Breast Cancer
Interventions
DRUG

SKB264

"SKB264 :5 mg/kg, IV (in the vein) on day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Eribulin:1.4mg/m2, IV (in the vein) on day 1 and Day 8 of each 281day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Capecitabine:1000-1250mg/m2, po,bid, from day 1 to Day 15 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Gemcitabine:800-1000 mg/m2, IV (in the vein) on day 1 and Day 8 of each 281day cycle. Number of Cycles: until progression or unacceptable toxicity develops.~Vinorelbine:25 mg/m2, IV (in the vein) on day 1 and Day 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."

Trial Locations (2)

100021

Cancer Hospital Chinese Academy of Medical Science, Beijing

210029

Jiangsu Province Hospital, Nanjing

All Listed Sponsors
lead

Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

INDUSTRY