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The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyrotinib and docetaxel plus trastuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel, trastuzumab | Drug | Docetaxel and trastuzumab once per cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel | Peak Plasma Concentration (Cmax) of pyrotinib | Approximately 2 months |
| Pharmacokinetic parameter: AUC of pyrotinib and docetaxel | Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel | Approximately 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate | Approximately 17 months |
| AEs+SAEs | Adverse Events and Serious Adverse Events | Approximately 17 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39024777 | Derived | Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| C000622954 | pyrotinib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Pyrotinib | Drug | Pyrotinib 400/320 mg orally daily |
|
| λz | Approximately 6 months |
| The incidence of≥3 grade diarrhea with different treatment | Approximately 17 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |