Real-world Outcomes in HER2-positive Metastatic Breast Cancer with Trastuzumab Deruxtecan
Data Collection
Collected from past medical records and data - RetrospectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 20, 2025
Actual date on which the first participant was enrolled.This study will utilize a longitudinal, demographically and geographically diverse database derived from Electronic Health Record data. No study medication will be supplied or administered for this protocol. The primary research objective is to describe the real-world progression-free survival (rwPFS) in HER2+ mBC patients who initiated a subsequent line of therapy (LOT) after a T-DXd-containing LOT in the metastatic setting. Secondary research objectives include describing the real-world overall survival (rwOS), patient demographics and clinical characteristics, real-world time to next treatment (rwTTNT), and real-world time to treatment discontinuation (rwTTD) in HER2+ mBC patients who initiated a subsequent LOT after a T-DXd-containing LOT in the metastatic setting. Treatment patterns and sequencing in HER2+ mBC patients for subsequent LOTs following initial treatment with T-DXd will also be assessed.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.228 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria Patients must meet all the inclusion criteria below to be included in the study population: 1. Patients with evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011. 2. Patients aged ≥18 years old at mBC diagnosis date. 3. Patients with ≥1 T-DXd-containing LOT in the metastatic setting. 4. Patients with evidence of a subsequent LOT following the first T-DXd-containing LOT in the metastatic setting. The LOT subsequent to the first T-DXd-containing LOT in the metastatic setting will be the index LOT. Index date will be the index LOT start date. 5. Patients whose closest HER2 test result (defined as immunohistochemistry \[IHC\] 3+ or in situ hybridization \[ISH\]+) recorded prior to or on the index date was a HER2+ test result. 6. Patients with index date occurring at least 90 days prior to end of study period (March 31st, 2024). Exclusion Criteria No exclusion criteria will be imposed.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location