This study is aimed to evaluate the efficacy and safety of Sacituzumab Tirumotecan combined with Toripalimab for first-line treatment of PD-L1 positive unresectable Locally Advanced/metastatic triple negative breast cancer (a/mTNBC).
Female patients with breast cancer aged >= 18 years.
Based on the pathological report of the latest biopsy or other pathological specimens, the histology and/or cytology are confirmed as invasive breast cancer, and the following conditions are met: a) Pathological classification: ER <= 10%, PR <= 10%; HER2 negative (IHC 0, 1+, 2+and FISH negative); Note: Subjects with initial histopathological diagnosis of HR>10% or HER2+breast cancer and recent pathological findings of metastatic lesions meeting the above conditions are allowed to be included in the study. b) Tumor staging: locally advanced, recurrent, or metastatic tumors that cannot be surgically removed; Note: Patients who have received perioperative treatment in the past are required to have a disease-free survival period of >= 6 months;
ECOG overall state is 0-1.
Have not received systematic treatment for advanced diseases.
Patients with central nervous system metastases.
Received radiotherapy, endocrine therapy, chemotherapy, surgical treatment (excluding local puncture or biopsy) or molecular targeted therapy during the recurrence/metastasis stage.
Participated in clinical trials of other drugs within 4 weeks prior to enrollment.
Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies, or any other antibodies or drugs that specifically target T cell co stimulatory or checkpoint pathways.
Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Southwest Hospital, China
Collaborator