DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form; 2. Ages≥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 therapy for breast cancer, as assessed by site. 6. At least one measurable lesion according to RECIST v1.1 criteria; 7. Cardiac function: New York Heart Association (NYHA) class \<3; left ventricular eject