Sacituzumab Tirumotecan Plus Anlotinib for Metastatic Triple Negative Breast Cancer
An Open-label, Single-arm, Multicenter Phase I/II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Anlotinib in Previously Treated Metastatic Triple Negative Breast Cancer (mTNBC).
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)
Time frame: up to approximately 60 months
Safety and the recommended phase 2 dose (RP2D)
Time frame: Up to Day 21
Secondary Endpoints
Disease control response (DCR)
Duration of response (DOR)
Progression-free survival (PFS)
Eligibility Criteria
Inclusion Criteria: * 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 pathological specimen, including: 1. Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); 2. Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC. * Patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least one line of standard of care regimens, including: 1. Any treatment received by the patients regardless of triple-negative state can be included as one of the standard of care regimens; 2. For neoadjuvant and/or adjuvant chemotherapy, if relapse or disease progression to unresectable l…
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