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NCT07244874PHASE2NOT_YET_RECRUITING

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

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Key Facts

Study type
INTERVENTIONAL
Conditions
TNBC - Triple-Negative Breast Cancer, PD-L1 Positive
Interventions
Sacituzumab tirumotecan, Toripalimab
Enrollment
41 participants
Primary completion
Jan 2028
Study completion
Jul 2029
First posted
Nov 2025
Last updated
Nov 2025

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

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov