NCT05755048

FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 314 (estimated)
• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Detailed description

This study is a multicenter, open-label, randomized controlled phase III clinical study to compare the efficacy and safety of FS-1502 versus T-DM1 in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Patients who meet the inclusion and exclusion criteria will be randomized into the test group (FS-1502) or control group (T-DM1) in a 1:1 ratio. Patients in the test group will receive FS-1502 2.3 mg/kg, and those in the control group will receive T-DM1 3.6 mg/kg, by intravenous drip every 3 weeks. Patients will be treated until disease progression (PD), intolerable toxicity, withdrawal of consent, death, or other protocol-specified reasons. According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1), tumor assessment will be performed every 6 weeks (± 7 days) for the first 12 months and every 12 weeks (± 7 days) after 12 months until PD, withdrawal of consent, or death. Efficacy evaluation will be performed by the investigator and the Independent Review Committee (IRC), respectively.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)	Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.
BIOLOGICAL	Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)	Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).

Timeline

• Start date: 2023-03-28
• Primary completion: 2025-07-30
• Completion: 2026-01-31
• First posted: 2023-03-06
• Last updated: 2023-09-01

Locations

56 sites across 1 country: China