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| Name | Class |
|---|---|
| Liaoning Cancer Hospital & Institute | OTHER |
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Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder identification tools is warranted. This phase II trial aims to identify a precision TNBC population suitable for de-escalated neoadjuvant therapy with sacituzumab govitecan plus tislelizumab, based on differential Trop-2 expression (±) and PD-L1 status (CPS >10% vs. <10%). Primary endpoints include pCR rate and safety; exploratory biomarker analyses will assess mechanisms of response/resistance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SG+I | Experimental | SG 10mg/kg, d1,d8 q3w + I 200mg, d1 q3w 6 cycles (18 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SG+I | Drug | SG 10mg/kg, d1,d8 q3w + I 200mg, d1 q3w 6 cycles (18 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) rate | To evaluate the pathological complete response (pCR) rate (ypT0/Tis ypN0) following neoadjuvant sacituzumab govitecan plus immunotherapy (SG/I) in biomarker-selected TNBC | From enrollment to the end of treatment at 24 weeks |
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Inclusion Criteria:
Serum amylase ≤ 1.5×ULN and serum lipase ≤ 1.5×ULN.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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