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

Daiichi Sankyo

Status: Completed

Conditions: HER2-positive Breast Cancer

Treatments: Other: No drug

Study type: Observational

Funder types: Industry

Identifiers

NCT06833268

U31402-0010-NIS-MA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

228 participants in 1 patient group

HER2-positive breast cancer

Description:

Patients diagnosed with HER2-positive metastatic breast cancer who initiated a subsequent LOT after the initial T-DXd-containing LOT in the metastatic setting.

Treatment:

Other: No drug