NCT05904964

Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)

Disitamab Vedotin or Endocrine Therapy for Patients With Metastatic Breast Cancer With Hormone Receptor-positive and HER2-low-expression

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%. However, this type of patients lack ideal therapeutic drugs after the failure of first-line standard endocrine therapy, and the median overall survival time is only 30 months. Therefore, finding more efficient and safe therapeutic drugs for these patients has become a big clinical challenge at present. Disitamab Vedotin (DV), as a new class I Antibody-Drug Conjugates drug, can achieve high efficiency and precise tumor killing effect with low toxicity. According to previous study with same sample size, DV also showed good efficacy in metastatic breast cancer with Hormone receptor positive and HER2- low expression as a posterior line treatment.Therefore, we intend to explore the efficacy and safety of DV in the treatment of HER2-low expressioin /Hormone receptor positive metastatic breast cancer patients with endocrine resistance through a scientifically designed, randomized, phase III clinical study.

Conditions

• HR Positive/HER2 Low Expression Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Disitamab vedotin	Disitamab Vedotin 2mg/kg was injected every 2 weeks,
OTHER	Endocrine therapy	Doctors choose endocrine therapy independently

Timeline

• Start date: 2023-07-01
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2023-06-15
• Last updated: 2023-06-22

Locations

3 sites across 1 country: China