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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyrotinib, trastuzumab, paclitaxel-albumin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib, trastuzumab, paclitaxel-albumin | Drug | pyrotinib: 400mg orally daily; trastuzumab: 8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles; paclitaxel-albumin: 260mg/m2, every 3 week, a total of 6 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by the investigators | pCR | Approximately 5 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 4 weeks after Cycle 6, each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | EFS | Following surgery until year 2 |
| Objective Response Rate | ORR | Baseline up to cycle 6 (assessed at Baseline, at the time of pre-surgery), up to approximately 5 months after neoadjuvant (each cycle is 21 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbin Zhou, Professor | Contact | 025-68308162 | Zhouwenbin@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| minimal residual lesions | MRD | Following surgery until year 2 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |