EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
- Registration Number
- NCT05458401
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- 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.
- Any participant who does not meet all inclusion criteria noted above.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Trastuzumab Deruxtecan (T-DXd) Cohort Trastuzumab deruxtecan Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).
- Primary Outcome Measures
Name Time Method Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd) From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months 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.
- Secondary Outcome Measures
Name Time Method Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd) Prior to time of T-DXd initiation Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd 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) 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) Prior to time of T-DXd initiation Patients who received prophylaxis treatment for nausea and/or vomiting will be reported.
Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd) From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months Real world progression-free survival (rwPFS) is defined as the time from T-DXd initiation to the earliest of death or progression.
Trial Locations
- Locations (21)
St. Vincent's Private Hospital
🇮🇪Dublin, Ireland
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Breast Center Humanitas Cancer Center IRCCS Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Centro di riferimento Oncologico (CRO), National Cancer Institute
🇮🇹Aviano, Pordenone, Italy
National Cancer Instutute 'Fondazione Pascale
🇮🇹Naples, Italy
Institute Oncology Veneto
🇮🇹Padua, Italy
Universita Campus Bio-Medico Di Roma
🇮🇹Rome, Italy
Policlinico Umberto I Di Roma
🇮🇹Rome, Italy
Fondazione Policlinico Univeritario Agostino Gemeli
🇮🇹Rome, Italy
Hospital General Universitario De Alicante
🇪🇸Alicante, Spain
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