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This study aims to optimize neoadjuvant therapy for HER2-positive breast cancer by implementing a dynamic monitoring-guided treatment strategy. Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody-drug conjugate) combined with pertuzumab. The primary objective is to evaluate whether this sequential treatment strategy improves the pathological complete response (pCR) rate while maintaining safety. The study will also explore the value of dynamic efficacy monitoring in guiding treatment adjustments and assess the safety and tolerability of the regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811+Pertuzumab | Experimental | Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody-drug conjugate) combined with pertuzumab. |
|
| trastuzumab, pyrotinib, and nab-paclitaxe | Active Comparator | Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients will initially receive trastuzumab, pyrotinib, and albumin-bound paclitaxel. Those who do not achieve a radiological response after Cycle 2 will switch to SHR-A1811 (a HER2-targeted antibody | Drug | Drug: SHR-A1811 Drug: Pertuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| tpCR | Total pathological complete response (tpCR: ypT0-is/ypN0) | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| EFS | Event-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| bpCR | Breast pathological complete response (bpCR:ypT0-is) | At the time of surgery |
| ORR | Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid |
Inclusion Criteria:
Exclusion Criteria:
6.Individuals with a known history of allergies to the drug components of this protocol; 7.Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
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| Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen. | Drug | Patients will initially receive trastuzumab, pyrotinib, and nab-paclitaxel. Those who achieve a partial response (PR) or complete response (CR) after cycle 2 will continue on the same regimen. |
|
| During 24 weeks of the neoadjuvant treatment |
| Incidence of Adverse Events | Incidence of Adverse Events | from consent to 28 days after last dose |
| ID | Term |
|---|---|
| C000622954 | pyrotinib |
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