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A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Database to describe 3L and 4L real-world (rw) outcomes (e.g. time to next treatment, time to discontinuation, and overal survival) of the tucatinib-trastuzumab-capecitabine triplet therapy immediately following T-DXd therapy in patients diagnosed with HER2+ metastatic breast cancer (mBC) in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3L+4L tucatinib triplet patients | Non-interventional, retrospective cohort analysis of participants receiving the tucatinib triplet in the 3L or 4L setting immediately following T-DXd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tucatinib | Drug | As provided in real world practice. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Next Treatment | Time to next treatment defined as the time in months from the initiation of therapy to the initiation of subsequent LOT or death. | 1 Year |
| Time to Discontinuation | Time to treatment discontinuation defined as the time in months from initiation of therapy to discontinuation for any reason or death. | 1 Year |
| Overall survival (OS) | OS will be defined as the time in months from initiation of therapy to death from any cause. | 1 Year |
| real-world Progression free survival (rwPFS) | rwPFS will be defined as time in months from initiation of therapy to progression or death from any cause. | 1 Year |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria:
Patients meeting any of the following criteria will not be included in the study:
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The study will include participants in the US Flatiron Dataset diagnosed with HER2+ mBC treated with the tucatinib triplet in the post-T-DXd setting.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10001 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Trastuzumab |
| Drug |
As provided in real world practice. |
|
| Capecitabine | Drug | As provided in real world practice. |
|
| ID | Term |
|---|---|
| D001943 | 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 |
|---|---|
| C000705452 | tucatinib |
| D000068878 | Trastuzumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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 |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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