NCT06851299

The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.

Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.

Detailed description

This prospective, multicenter, randomized controlled study aims to evaluate the 3-month treatment efficacy (ORR) of three therapeutic strategies-ADC monotherapy, ADC in combination with immunotherapy, and ADC in combination with immunotherapy and anti-angiogenesis-in patients with advanced breast cancer, and to assess potential adverse events related to the treatment regimens. Participants will receive treatment with a Trop-2-targeting ADC drug containing a TOP1 inhibitor (such as Gosituzumab or SKB264), in accordance with the defined protocol. Regular assessments will include imaging, histopathological analysis, and safety monitoring. The objective of this study is to provide novel treatment strategies for triple-negative breast cancer by evaluating the efficacy and safety of trop2-ADC+ immunotherapy + antiangiogenic agents and trop2-ADC+ antiangiogenic agents versus trop2-ADC monotherapy in patients with metastatic triple-negative breast cancer (mTNBC).

Conditions

• Metastatic Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	trop2-ADC	Accept ADC monotherapy
DRUG	ADC +anti-angiogenic drug	Accept ADC combined with anti-angiogenic drug
DRUG	ADC + PD1 monoclonal antibody +anti-angiogenic drug	ADC combined with PD1 monoclonal antibody and anti-angiogenic drug

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-04-30
• Completion: 2028-02-29
• First posted: 2025-02-28
• Last updated: 2025-02-28

Locations

1 site across 1 country: China