drugset / Trial / NCT06081959

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

NCT06081959

Phase 3 Recruiting 376 enrolled Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.

Timeline

Start
2023-10-31
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1000 mg/m2 Oral
Comparator Capecitabine Small molecule 1250 mg/m2 Oral
Comparator Eribulin Small molecule 1.4 mg/m2 Intravenous
Comparator Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified Intravenous
Comparator Vinorelbine Small molecule 25 mg/m2 Intravenous

Indications