Sac-TMT Combined With Toripalimab for First-line Treatment of PD-L1 Positive a/mTNBC
A Single Arm, Phase II Study of Sacituzumab Tirumotecan(Sac-TMT) Combined With Toripalimab for First-line Treatment of PD-L1 Positive Unresectable Locally Advanced/Metastatic Triple Negative Breast Cancer (a/mTNBC)
Sponsor: Tianjin Medical University Cancer Institute and Hospital + Southwest Hospital, China
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR)
Time frame: Up to approximately 15 months
Secondary Endpoints
Progression-Free-Survival
Duration of Response
Overall Survival
Eligibility Criteria
Inclusion Criteria: 1. Female patients with breast cancer aged \>= 18 years. 2. 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; 3. ECOG overall state is 0-1. 4. Have not received systematic treatment for advanced diseases. 5. There are tissue samples available for PD-L1 testing, and the test…
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