Study design for DESTINY-Breast Respond HER2-low Europe - T-DXd in patients with HER2-low advanced breast cancer

Sep 21, 2026

Uploaded by Liam

Clinical Trial Protocol describing the DESTINY-Breast Respond HER2-low Europe study (NCT05945732) evaluating trastuzumab deruxtecan (T-DXd; Enhertu) in routine care for advanced HER2-low metastatic breast cancer. The non-interventional, prospective, multi-center, multi-country observational design plans enrollment of 1350 patients across 216 sites in 12 European countries. Collected outcomes include effectiveness, safety and tolerability, patient-reported outcomes, treatment patterns, geriatric health status, and HER2 testing approaches.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Study overview

Trial design and objectives

Plain language summary

Enrollment, sites, and countries

Outcomes and assessments

Registration and timeline

Keywords and clinical background

Clinical Trial Protocol Study design for DESTINY-Breast Respond HER2-low Europe: T-DXd in patients with HER2-low advanced breast cancer Valentina Guarneri*,1,2, Jos Lu´ıs Passos Coelho3, Francois P Duhoux4, Daniel Egle5, Jos ´Angel Garc-Senz6, Frdrique Penault-Llorca7, Katri Selander8,9, Hans Wildiers10, Khalil Zaman11, Petra Laeis12, Markus Lucerna12 & Jean-Yves Pierga13 1 Medical Oncology 2, Veneto Institute of Oncology (IOV), IRCCS, Via Gattamelata, 64, 35128 Padova PD, Italy 2 Department of Surgery, Oncology & Gastroenterology, University of Padova, Via Nicolo` Giustiniani, 2, 35128 Padova PD, Italy 3 Oncology Department, Hospital da Luz, Av. Lus´􀀂ada 100, 1500-650 Lisbon, Portugal 4 Department of Medical Oncology, King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Av. Hippocrate 10, 1200 Brussels, Belgium 5 Department of Gynaecology & Obstetrics, Medical University of Innsbruck, Christoph-Probst-Platz 1, Innrain 52 A, Fritz-Pregl-Straße 3, 6020 Innsbruck, Austria 6 Department of Medical Oncology, Hospital Cl´ınico San Carlos, Instituto de Investigacin Sanitaria Hospital Cl´ınico San Carlos (IdISSC), Calle del Prof Martin Lagos, s/n, Moncloa-Aravaca, 28040 Madrid, Spain 7 Centre Jean Perrin, Universit Clermont Auvergne, INSERM, U1240 Imagerie Molculaire Et Stratgies Thranostiques, Rue Montalebert, 63000 Clermont-Ferrand, France 8 Department of Oncology & Radiation Therapy, Oulu University Hospital, Kajaanintie 50, 90220 Oulu, Finland 9 Cancer Research & Translational Medicine Research Unit, University of Oulu, Pentti Kaiteran katu 1, 90570 Oulu, Finland 10 Department of General Medical Oncology, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium 11 Department of Oncology, Lausanne University Hospital, University of Lausanne, 1011 Lausanne, Switzerland 12 Daiichi Sankyo Europe GmbH, Zielstattstraße 48 81379 Munich, Germany 13 Department of Medical Oncology, Institut Curie, Universit Paris Cit, 75005 Paris, France *Author for correspondence: [valentina.guarneri@unipd.it](valentina.guarneri@unipd.it) Trastuzumab deruxtecan (T-DXd) is approved for the treatment of human epidermal growth factor receptor 2 (HER2)-low metastatic breast cancer (mBC) . Results on T-DXd treatment in HER2-low mBC have so far been limited to clinical trials. DESTINY-Breast Respond HER2-low Europe (NCT05945732) is a multi-center, multi-country, observational, prospective, non-interventional study planning to enroll 1350 patients from 216 sites receiving T-DXd or conventional chemotherapy as their routine clinical care for advanced stage breast cancer in 12 European countries. This non-interventional study will provide realworld insight into T-DXd treatment for HER2-low mBC with data on effectiveness, safety and tolerability, patient-reported outcomes, treatment patterns, geriatric health status and HER2 testing. This will be beneficial for improving guidance to maximize patient treatment benefit. Plain language summary: Trastuzumab deruxtecan (T-DXd; Enhertu􀀂R ) is a medicine approved to treat cancers that produce a protein called HER2 on the surface of cancer cells. T-DXd works by targeting the HER2 protein to deliver chemotherapy directly to cancer cells. Until recently, breast cancers were classified as HER2-positive (high level of HER2 protein on cancer cells) or HER2-negative (very low level/no HER2 protein on cancer cells) . T-DXd was approved for treating patients with HER2-positive advanced breast cancer in Europe in 2022 . In 2023 the DESTINY-Breast04 clinical trial showed that T-DXd was more effective than current standard chemotherapies, when treating advanced breast cancer patients with low levels of the HER2 protein (historically classified as HER2-negative cancer) . This trial led to the approval of T-DXd for treating advanced HER2-low breast cancer, providing a new treatment option for 50–60% of breast cancer patients. More information is needed about T-DXd treatment i

FAQs

What is the DESTINY-Breast Respond HER2-low Europe study evaluating?

The protocol evaluates trastuzumab deruxtecan (T-DXd) in routine clinical care for patients with HER2-low advanced breast cancer, focusing on effectiveness and real-world safety and tolerability.

How is the study designed and where will it be conducted?

It is a non-interventional, prospective observational study planned to enroll 1350 patients from 216 sites across 12 European countries.

What kinds of data will be collected during the study?

The study will collect data on effectiveness, safety and tolerability, patient-reported outcomes, treatment patterns, geriatric health status, and HER2 testing and how HER2 levels are being tested.

Sep 21, 2026

Uploaded by Liam