NCT06081959

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

A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	SKB264	IV infusion on day 1 and Day 15 of each 28 day cycle
DRUG	Eribulin	1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
DRUG	Capecitabine	1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle
DRUG	Gemcitabine	1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle
DRUG	Vinorelbine	25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Timeline

• Start date: 2023-10-31
• Primary completion: 2026-03-31
• Completion: 2027-12-31
• First posted: 2023-10-13
• Last updated: 2025-12-05

Locations

1 site across 1 country: China