Clinical trial NCT05458401: EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
Official title: EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan Through a Named Patient Program (EUROPA T-DXd)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HER2-positive Breast Cancer
Keywords: HER2-positive Breast Cancer
Trastuzumab Deruxtecan
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The real world data (RWD) collection will include adult participants with advanced/metastatic HER2+ breast cancer treated in routine clinical practice. The collection of RWD will be optional and independent to eligibility for the NPP. It will include those who have already completed T-DXd treatment under the NPP, as well as patients whose T-DXd treatment remains ongoing.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Real-World Time-to-Treatment Discontinuation In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
timeFrame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
Secondary outcomes:
measure: Type of Prior Targeted HER2-targeted Treatments In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
timeFrame: Prior to time of T-DXd initiation
measure: Number of Participants Who Discontinued Trastuzumab Deruxtecan (T-DXd) In Participants Treated With T-DXd
timeFrame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
measure: Number of Participants With Treatment-emergent Adverse Events In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
timeFrame: From the time from T-DXd initiation to the date of T-DXd discontinuation, up to 14 months
measure: Number of Participants Who Received Prophylaxis Treatment In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
timeFrame: Prior to time of T-DXd initiation
measure: Real World Progression-free Survival In Participants Treated With Trastuzumab Deruxtecan (T-DXd)
timeFrame: From the time of T-DXd initiation to the date of T-DXd discontinuation, withdrawal, or disease progression, up to 14 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. Vincent's Private Hospital
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
city: Rozzano
country: Italy
facility: Breast Center Humanitas Cancer Center IRCCS Istituto Clinico Humanitas
state: Milano
city: Aviano
country: Italy
facility: Centro di riferimento Oncologico (CRO), National Cancer Institute
state: Pordenone
city: Naples
country: Italy
facility: National Cancer Instutute 'Fondazione Pascale
city: Padua
country: Italy
facility: Institute Oncology Veneto
city: Rome
country: Italy
facility: Universita Campus Bio-Medico Di Roma
city: Rome
country: Italy
facility: Policlinico Umberto I Di Roma
city: Rome
country: Italy
facility: Fondazione Policlinico Univeritario Agostino Gemeli
city: Alicante
country: Spain
facility: Hospital General Universitario De Alicante
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Hospital Quiron Salud Barcelona
city: Barcelona
country: Spain
facility: Hospital Val d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Gerona
country: Spain
facility: ICO Girona
city: Jaén
country: Spain
facility: Hospital Universitario de Jaen
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: