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To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFU+Toripalimab+Chemotherapy | Experimental | High Intensity Focused Ultrasoun, followed by Toripalimab 240 mg + epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 × 4 cycles → Toripalimab240 mg + carboplatin AUC 5 + nab-paclitaxel 260 mg/m2 IVD × 4 cycles every 3 weeks for 8 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripalimab 240mg |
| |
| Epirubicin |
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Pathologic complete response rate | 6 months |
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Inclusion Criteria:
WBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN;
9) The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.
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Exclusion Criteria:
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| Drug |
90mg/m2,IVD,q3w |
|
| High Intensity Focused Ultrasoun | Procedure | HIFU treatment at lesion site |
|
| Cyclophosphamide | Drug | 600mg/m2,IVD,q3w |
|
| Carboplatin | Drug | AUC 5,IVD,q3w |
|
| Nab-paclitaxel | Drug | 260mg/m2,IVD,q3w |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D016190 | Carboplatin |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D056831 | Coordination Complexes |
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