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

Phase 3 Active not recruiting 254 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy of SKB264 in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed second-line or above prior standard of care

Timeline

Start: 2022-06-10
Primary completion: 2023-11-30
Completion: 2027-06-30

Publications

Yin Y, Fan Y, Ouyang Q, Song L, Wang X, Li W, Li M, Yan X, Wang S, Sun T, Teng Y, Tang X, Tong Z, Sun Z, Ge J, Jin X, Diao Y, Liu G, Xu B. Sacituzumab tirumotecan in previously treated metastatic triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2025 Jun;31(6):1969-1975. doi: 10.1038/s41591-025-03630-w. Epub 2025 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Capecitabine	Small molecule	1250 mg/m2	Oral
Subject	Eribulin	Small molecule	1.4 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Comparator	Sacituzumab Tirumotecan	Other / unclassified	5 mg/kg	Intravenous
Subject	Vinorelbine	Small molecule	25 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications