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This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75mg/m2 iv escalating to 100mg/m2 iv 3-weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| tpCR | total pathological complete response | Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 6) |
| Measure | Description | Time Frame |
|---|---|---|
| EFS | Event-free survival | Randomization up to a maximum of 329 weeks |
| DFS | Disease-free survival | Randomization up to a maximum of 329 weeks |
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Inclusion Criteria:
(1) Blood routine: neutrophil (ANC) >= 1.5×10^9/L; platelet count (PLT) >= 90×10^9/L; hemoglobin (Hb) >= 90 g/L; (2) Blood biochemistry: total bilirubin (TBIL) <= upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 1.5×ULN; alkaline phosphatase <= 2.5×ULN; urea nitrogen (BUN) and creatinine (Cr) <= 1.5×ULN; (3) Echocardiography: left ventricular ejection fraction (LVEF) >= 60%; (4) 12-lead ECG: Fridericia-corrected QT interval (QTcF) < 470 msec; 7. Female patients who are not menopausal or surgically sterilized: agree to abstain from sex or use effective contraceptive methods during treatment and for at least 7 months after the last dose in the study treatment; 8. Voluntarily join the study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
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| Carboplatin |
| Drug |
AUC=6 min/mL iv 3-weekly |
|
| Inetetamab | Drug | 8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly |
|
|
| Pyrotinib | Drug | 400mg orally daily |
|
| DDFS | Distant disease free survival | Randomization up to a maximum of 329 weeks |
| OS | Overall survival | Up to 2 years |
| CNS-DFS | Central nervous system disease-free survival | Randomization up to a maximum of 329 weeks |
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| C000622954 | pyrotinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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