Sacituzumab Tirumotecan Plus Tagitanlimab in Previously Treated Locally Advanced or Metastatic Triple Negative Breast Cancer
An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Sponsor: Tianjin Medical University Cancer Institute and Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: up to approximately 60 months
Secondary Endpoints
Progression Free Survival (PFS) as Assessed by Investigator per RECIST Version 1.1
Overall Survival (OS)
Disease control response (DCR) as Assessed by Investigator per RECIST Version 1.1
Eligibility Criteria
Key inclusion criteria include but are not limited to: * Age ≥ 18 years at the time of signing informed consent. * Histologically and/or cytologically confirmed triple-negative breast cancer (TNBC) based on the most recent biopsy or other pathological specimens, including: 1. Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER2 is 2+ by IHC, negative HER2 expression must be confirmed by fluorescencein situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC. 2. Tumor stage: locally advanced, recurrent, or metastatic TNBC; locally advanced cases must be confirmed by the investigator as unsuitable for curative surgical resection. * Patients with unresectable locally advanced or metastatic triple-negative breast cancer: 1. Those who have received chemotherapy combined with a PD-(L)1 inhibitor as first-line treatment for…
Read full criteria on CT.gov →✦ Analyst Commentary
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