NCT07071337

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 430 (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 who have previously failed endocrine therapy.

Detailed description

This is a randomized, open-label, multicenter phase 3 clinical study to evaluate the efficacy and safety of SKB264 monotherapy versus investigator's choice of chemotherapy (ICC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy and have not recieved systemic chemotherapy for locally advanced, relapsed, or metastatic stages.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	SKB264	5mg/kg, IV on Day 1 and Day 15 of each 28 day cycle
DRUG	Nab-paclitaxel	100 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks
DRUG	Paclitaxel	90 mg/m\^2, IV, on Days 1, 8, and 15 every 4 weeks; or 80 mg/m\^2, IV, weekly, every 3 weeks
DRUG	Capecitabine	1000-1250 mg/m\^2, orally, Days 1-14, twice daily, every 3 weeks

Timeline

• Start date: 2025-07-18
• Primary completion: 2027-07-01
• Completion: 2031-02-01
• First posted: 2025-07-17
• Last updated: 2025-12-11

Locations

2 sites across 1 country: China