A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
A Randomized, Open-label, Multicenter Phase III Clinical Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Breast Cancer Who Have Previously Failed Endocrine Therapy
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
430 participants
Jul 18, 2025
INTERVENTIONAL
Conditions
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 who have previously failed endocrine therapy.
Eligibility
Plain Language Summary
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Interventions
5mg/kg, IV on Day 1 and Day 15 of each 28 day cycle
100 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks
90 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks; or 80 mg/m\^2, IV, weekly, every 3 weeks
1000-1250 mg/m\^2, orally, Days 1-14, twice daily, every 3 weeks
Locations(2)
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For the most up-to-date information, visit the official listing.
NCT07071337