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

NCT05458401 | Completed DMC FDA Drug

• 1 other identifier: DS8201-0002-EAP-MA
• Study Type: observational
• Target: 256
• Locations: 3 countries
• Sites: 21

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.

Conditions

HER2-positive Breast Cancer

Keywords

HER2-positive Breast Cancer; Trastuzumab Deruxtecan

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

• 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

• 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

Study Arms (1)

Trastuzumab Deruxtecan (T-DXd) Cohort

Patients with advanced/metastatic HER2-positive breast cancer who are receiving treatment (or previously treated) with trastuzumab deruxtecan (T-DXd).

Drug: Trastuzumab deruxtecan

Interventions

Trastuzumab deruxtecan DRUG

No drug will be administered during this study.

Also known as: T-DXd

Trastuzumab Deruxtecan (T-DXd) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (21)

St. Vincent's Private Hospital

Dublin, D04 N2EO, Ireland

Location

St. Vincent's University Hospital

Dublin, D04 T6F4, Ireland

Location

Breast Center Humanitas Cancer Center IRCCS Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Centro di riferimento Oncologico (CRO), National Cancer Institute

Aviano, Pordenone, 33081, Italy

Location

National Cancer Instutute 'Fondazione Pascale

Naples, 80131, Italy

Location

Institute Oncology Veneto

Padua, 35128, Italy

Location

Universita Campus Bio-Medico Di Roma

Rome, 00128, Italy

Location

Policlinico Umberto I Di Roma

Rome, 00161, Italy

Location

Fondazione Policlinico Univeritario Agostino Gemeli

Rome, 00168, Italy

Location

Hospital General Universitario De Alicante

Alicante, 03010, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Hospital Quiron Salud Barcelona

Barcelona, 08023, Spain

Location

Hospital Val d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

ICO Girona

Girona, 17007, Spain

Location

Hospital Universitario de Jaen

Jaén, 23007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Fundacion Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Related Publications (1)

• Saura C, Wildiers H, Bianchini G, Garcia-Saenz JA, Allignol A, Logue A, Lucerna M, Stamenitis S, De Laurentiis M. European experience of patients with HER2-positive advanced/metastatic breast cancer accessing trastuzumab deruxtecan through a named patient program: the EUROPA T-DXd study. Front Oncol. 2025 Oct 14;15:1650981. doi: 10.3389/fonc.2025.1650981. eCollection 2025.

  PMID: 41164130 DERIVED

MeSH Terms

Interventions

trastuzumab deruxtecan

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: November 11, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7); ES (12); IE (2)