Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOT
This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal
| Condition(s) | HR+/HER2- Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+/HER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR) |
| Who can participate | Inclusion Criteria: 1. Female patients aged 18-75 years old; 2. ECOG score is 0-1 points; 3. breast cancer meets the following standards: Histologically confirmed invasive breast cancer with tumor diameter\>1cm (T1c-3; N0-3; M0). All patients were pathohistologically confirmed as HR+/HER2- breast cancer. According to the breast cancer diagnosis and treatment guidelines and specifications of the Chinese Anti Cancer Association (2021 version), Luminal B is divided into Luminal B (HER2 negative) and Luminal B (HER2 positive). Luminal B (HER2 negative) is ER/PR positive, HER2 negative and Ki-67 proliferation index is high or PR low expression. Luminal type B (HER2 positive) is ER/PR positive, HER2 positive (protein overexpression or gene amplification), and Ki-67 in any state. Therefore, HR |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | First Affiliated Hospital of Zhejiang University |
| Locations | Hangzhou, China; Hangzhou, China; Harbin, China; Hefei, China; Jinhua, China; Nanchang, China (+5 more sites) |
| Start date | 2024-06-11 |
| NCT ID | NCT06611813 |
| Official listing | https://clinicaltrials.gov/study/NCT06611813 |