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NCT06389006Not yet recruiting

To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer

A Single-arm, Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer
RemeGen Co., Ltd.Phase 2ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Breast Cancer
Drug/Device/Intervention
Disitamab Vedotin for Injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
RemeGen Co., Ltd.
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 2
Start date
Apr 30, 2024
End date
Dec 31, 2026
Enrollment
79 participants
Primary outcome

Total pathological complete response (tpCR) rate

Summary

The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin
 combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low
 breast cancer

ICD-10 classifications
Malignant neoplasm of breastMalignant neoplasm of breastCarcinoma in situ of breast, unspecifiedMalignant neoplasm: Breast, unspecifiedOther carcinoma in situ of breast
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06389006
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06389006 through Pure Global AI's free database. This Phase 2 trial is sponsored by RemeGen Co., Ltd. and is currently Not yet recruiting. The study focuses on Breast Cancer. Target enrollment is 79 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.