Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan

Recruiting

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT06833268
• Lead Sponsor: Daiichi Sankyo

Brief Summary

This study will explore treatment patterns and clinical outcomes using the US-based Flatiron Health database to describe patients with HER2+ mBC who were previously treated with T-DXd to better characterize this population and inform internal decision making in this rapidly changing therapeutic landscape.

Detailed Description

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.

Study Timeline

• Study Start: 2025-01-20
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2025-06-16
• Study Completion: 2025-06-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world Progression-free Survival (rwPFS)	Index date (index LOT start date) to date of earliest disease progression >14 days after the index date or date of death, whichever occurs first, up to approximately 13 years 3 months	rwPFS is defined as the interval in months between the index date until the first evidence of progression or death as documented by Flatiron.

Secondary Outcome Measures

Name	Time	Method
Real-world Time to Next Treatment (rwTTNT)	Index date (index LOT start date) to next LOT start date or, in the absence of next LOT, death, whichever occurs first, up to approximately 13 years 3 months	rwTTNT is defined as the time in months between index date and initiation of next LOT, or death, whichever occurs first.
Real-world Time to Treatment Discontinuation (rwTTD)	Index date (index LOT start date) to date treatment is discontinued, up to approximately 13 years 3 months	rwTTD is defined as the time in months between index date and date of treatment discontinuation or death, whichever occurs first.
Treatment Patterns by Type of Line of Therapy	Index date (index LOT start date) to end of study period, up to approximately 13 years 3 months	Treatment patterns will be described by LOT (monotherapy, combination therapy, and treatment sequence).

Trial Locations

Locations (1)

Flatiron Health, Inc; 🇺🇸 New York, New York, United States