NCT03500380

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 301 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.

Conditions

• Breast Neoplasms
• Breast Diseases
• Capecitabine
• HER2-positive Breast Cancer
• HER2 Positive Breast Carcinoma
• HER2-positive Advanced Breast With Liver Metastases

Interventions

Type	Name	Description
DRUG	RC48-ADC	RC48-ADC 2.0 mg/kg IV every 14 days
DRUG	Lapatinib	Lapatinib 1250 mg orally once daily during each 21-day cycle.
DRUG	Capecitabine	Capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle.

Timeline

• Start date: 2018-04-24
• Primary completion: 2024-07-31
• Completion: 2024-12-31
• First posted: 2018-04-18
• Last updated: 2024-02-20

Locations

67 sites across 1 country: China