Clinical Trial

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)

Recruiting Phase 3
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Summary
Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+/HER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy for patients with HR+/HER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response(PCR)and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer.
Trial Details
NCT Number NCT06977893
Lead Sponsor First Affiliated Hospital of Zhejiang University
Conditions HR+/HER2- Breast Cancer
Enrollment 194 participants
Start Date 2025-03-24
Primary Completion 2027-03-23 (estimated)
Study Completion 2030-03-23 (estimated)
Updated on ClinicalTrials.gov 2025-05-18