NCT07071337View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

430

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

February 28, 2031

Conditions
Metastatic Breast Cancer
Interventions
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

Trial Locations (2)

100039

RECRUITING

The Fifth Medical Center of the Chinese PLA General Hospital, Beijing

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY