EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan

Daiichi Sankyo256 enrolled

Overview

A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment. To gain early insights on the use of T-DXd outside of a trial setting, patients with advanced/metastatic HER2+ breast cancer receiving treatment (or previously treated) with T-DXd through the NPP will be invited to participate.

The antibody-drug conjugate T-DXd has been granted conditional approval in the European Union as a single agent for adult patients with unresectable or metastatic HER2+ breast cancer who have previously received ≥2 HER2-based regimens. This was based on data from the Phase II DESTINY-Breast01 trial (NCT03248492). DS8201-0002-EAP-MA is a real world data (RWD) observational data collection inviting patients with advanced/metastatic HER2+ breast cancer receiving T-DXd through the NPP already to participate to help further understand the usage in a real world clinical setting.

Study Type

OBSERVATIONAL

Enrollment

256

Conditions

HER2-positive Breast Cancer

Interventions

Trastuzumab deruxtecanDRUG

No drug will be administered during this study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants for whom T-DXd treatment is indicated, according to the summary of product characteristics conditionally approved by the EMA, that are eligible for treatment with T-DXd through the NPP (i.e., those with advanced/metastatic HER2+ breast cancer who have received ≥ 2 prior anti-HER2-based regimens and have documentation of HER2 positive tumour status by a validated method) will be eligible for inclusion to this RWD collection, subject to providing written informed consent to participate. Exclusion Criteria: * Any participant who does not meet all inclusion criteria noted above.

Locations (21)

St. Vincent's Private Hospital

Dublin, Ireland

St. Vincent's University Hospital

Dublin, Ireland

Outcomes

Primary Outcomes

Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

Real-world time-to-treatment discontinuation (rwTTD) is defined as the time from trastuzumab deruxtecan initiation to discontinuation for any reason in patients with advanced/metastatic HER2+ breast cancer in a real-world clinical setting.

Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

Secondary Outcomes

Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

Time frame: Prior to time of T-DXd initiation

Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd

Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

Time frame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months

Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

Patients who received prophylaxis treatment for nausea and/or vomiting will be reported.

Time frame: Prior to time of T-DXd initiation

Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd)

Real world progression-free survival (rwPFS) is defined as the time from T-DXd initiation to the earliest of death or progression.

Time frame: From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months

Data from ClinicalTrials.gov

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