Metastatic HER2+ Advanced Breast Cancer
Conditions
Keywords
her2+, mBC, metastatic breast cancer, tukysa, tucatinib, breast neoplasm, Human epidermal growth factor receptor 2 positive
Brief summary
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.
Interventions
DRUGTucatinib
As provided in real world practice.
DRUGTrastuzumab
As provided in real world practice.
DRUGCapecitabine
As provided in real world practice.
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. mBC diagnosis between January 1, 2017 and 6 months prior to database cutoff 2. Evidence of human epidermal growth factor receptor 2 (HER2) receptor positivity prior to or up to 90 days following the mBC diagnosis date 3. At least 18 years old on the mBC diagnosis date 4. Treated with systemic anticancer treatment in the metastatic setting, i.e., post mBC diagnosis. 5. Treated with T-DXd in the 1L or 2L or 3L setting, followed immediately by the tucatinib triplet, and at least 1 additional prior HER2-targeted regimen
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study: 1. Patients with evidence of other cancers six months prior to the mBC diagnosis date will be identified with the following International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes in all databases: 140.xx - 195.xx, 200.xx - 208.xx, C00.xx - C76.xx, C81.xx - C96.xx. (exclude - ICD-9: 174.X, 175.X; ICD-10: C50.XX) 2. Patients treated with tucatinib prior to T-DXd 3. Patients participating in clinical trials 4. Patients receiving concomitant endocrine therapy on index line
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Treatment | 1 Year | Time to next treatment defined as the time in months from the initiation of therapy to the initiation of subsequent LOT or death. |
| Time to Discontinuation | 1 Year | Time to treatment discontinuation defined as the time in months from initiation of therapy to discontinuation for any reason or death. |
| Overall survival (OS) | 1 Year | OS will be defined as the time in months from initiation of therapy to death from any cause. |
| real-world Progression free survival (rwPFS) | 1 Year | rwPFS will be defined as time in months from initiation of therapy to progression or death from any cause. |
Countries
United States
Outcome results
None listed