DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer. |
| Who can participate | Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form; 2. Agesā„18 years; 3. Histopathologically confirmed invasive breast cancer, clinical stage T2-3 (tumor diameter \> 2 cm), cN0- 3, M0; 4. Invasive breast tumour tissue confirmed HER2-positive by the central laboratory, defined as HER2 protein expression of IHC 3+ by immunohistochemistry (IHC) or IHC 2+ with amplification by in situ hybridisation (ISH) (according to the HER2 Guidelines for Breast Cancer, 2019 edition); and specimens from the primary site of the tumour for HER2 testing (wax blocks, sections or fresh tissue are acceptable) can be provided for HER2 testing; 5. Subjects who tolerate and are scheduled to undergo radical breast cancer surgery and have not received any prior anti-tumour systemic thera |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | RemeGen Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2023-11-28 |
| NCT ID | NCT06178159 |
| Official listing | https://clinicaltrials.gov/study/NCT06178159 |