Enhertu 100 mg powder for concentrate for solution for infusion
Sponsors
Karolinska University Hospital, Medica Scientia Innovation Research S.L., Solti Group, Boehringer Ingelheim International GmbH, Universitaetsklinikum Ulm AöR
Conditions
Breast CancerHER2-positive or HER2-low early breast cancerHER2-positive unresectable locally recurrent or metastatic breast cancer (MBC).Metastatic breast cancerMetastatic breast cancersNon-metastatic HER2-positive Breast CancerPatients diagnosed with advanced or metastatic cancer treated with Trastuzumab Deruxtecan in the context of a clinical trial/expanded access/ compassionate use or standard treatmentPatients with HER2-positive
Phase 1
Phase 2
A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE
RecruitingCTIS2022-501504-95-00
Start: 2023-06-23Target: 402Updated: 2025-08-18
HER2-PREDICT: Translational study of tumor samples from patients treated with Trastuzumab Deruxtecan (T-DXd; DS-8201a)
Active, not recruitingCTIS2023-508830-33-00
Start: 2019-12-13Target: 180Updated: 2024-10-25
A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients (The DEMETHER Study)
RecruitingCTIS2023-507306-13-00
Start: 2025-04-13Target: 132Updated: 2025-07-24
A multicentre, prospective, open-label study with [68Ga]Ga-ABY-025 PET-imaging to characterize HER2-expression and explore the therapy-predictive value for HER2-antibody drug conjugates in patients with metastatic breast cancer (HER2-Ex PET)
Not yet recruitingCTIS2024-512721-89-00
Target: 70Updated: 2026-01-08
Upfront trastuzumab-deruxtecan plus capecitabine and bevacizumab for patients with HER2 positive metastatic colorectal cancer: the CHIMERA trial
RecruitingCTIS2024-519479-24-00
Start: 2025-11-21Target: 42Updated: 2025-10-07
A multicenter, multicohort, phase 2 platform trial to personalize second-line treatment intensity and targeting in HR-positive, HER2-negative metastatic breast cancer through an integrated liquid biopsy algorithm.
Not yet recruitingCTIS2025-523460-21-00
Target: 159Updated: 2026-03-31
Phase 3
SURVIVE HERoes – A randomized Secondary Adjuvant Treatment Intervention study comparing Trastuzumab-Deruxtecan to SOC therapy in eBC Patients with Molecular Relapse
RecruitingCTIS2024-516173-76-01
Start: 2025-04-22Target: 180Updated: 2024-12-20
Patient-Centered Study of Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-POsitive Metastatic Breast Cancer with Proactive Toxicity ManagementReflecting Real-World Clinical Practice / TOP-REAL Trial
Not yet recruitingCTIS2025-521805-41-00
Target: 175Updated: 2026-01-27