Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)
Status:
Recruiting
Trial end date:
2030-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University