NCT04400695

A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: RemeGen Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.

Detailed description

This study is a multi-center, randomized, open, parallel control to evaluate the effectiveness and safety of Phase III clinical trials of the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of locally advanced or metastatic breast cancer the study.The low expression of HER2 is defined as: the immunohistochemistry (IHC) confirmed by the central laboratory detects the expression of HER2 protein as IHC 2+ and the fluorescence in situ hybridization (FISH) detection has no amplification.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	RC48-ADC	RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks
DRUG	Paclitaxel Injection	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Docetaxel Injection	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Vinorelbine Tartrate Injection	Administered according to label, as one option for Physician's Choice (determined before randomization)
DRUG	Capecitabine Tablets	Administered according to label, as one option for Physician's Choice (determined before randomization)

Timeline

• Start date: 2020-09-29
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2020-05-22
• Last updated: 2024-01-24

Locations

1 site across 1 country: China