NCT05134519

RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent (RC48-ADC) for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression (Seraph)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.

Detailed description

A single-arm exploratory study was conducted in 20 patients with HER2-positive breast cancer to explore the effect of RC48 in HER2-positive neoadjuvant therapy (treatment regimen: RC482.0 mg/kg, intravenous drip, once every 2 weeks). After 4-6 cycles, surgery was performed to evaluate the effect of neoadjuvant chemotherapy. The latest reported data of T-DM1 in neoadjuvant therapy were compared to evaluate the non-inferiority of RC48.

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)	Regimen: RC48-ADC: 2.0 mg/kg, intravenous drip, once every 2 weeks,4-6 cycles

Timeline

• Start date: 2021-11-26
• Primary completion: 2024-09-30
• Completion: 2025-09-30
• First posted: 2021-11-26
• Last updated: 2021-11-26