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Search / Trial NCT05945732

DESTINY Breast Respond HER2-low Europe

Launched by DAIICHI SANKYO EUROPE, GMBH, A DAIICHI SANKYO COMPANY · Jul 6, 2023

Trial Information

Current as of August 27, 2025

Recruiting

Keywords

Unresectable Breast Cancer Metastatic Breast Cancer Her2 Low Expressing Breast Cancer Trastuzumab Deruxtecan Enhertu®

ClinConnect Summary

The DESTINY Breast Respond HER2-low Europe trial is studying a new treatment called trastuzumab deruxtecan (T-DXd) for adults with advanced breast cancer that is HER2-low expressing. This means the cancer cells have a lower level of a specific protein called HER2, which can affect how the cancer grows. The trial is looking for participants who have already received chemotherapy and either have cancer that cannot be surgically removed or have experienced a recurrence of their cancer within six months of finishing their last treatment.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of unresectable (unable to be removed) or metastatic (spread to other parts of the body) breast cancer. They also need to have documented HER2-low status. If you join the trial, you will receive the T-DXd treatment, and your health will be closely monitored by the research team. It’s important to note that pregnant or breastfeeding individuals cannot participate, and those currently involved in another clinical study that is not open can also not take part. This trial aims to see if T-DXd can provide a new treatment option for patients with this specific type of breast cancer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis of unresectable and/or mBC
  • Documented HER2-low status (IHC1+, IHC2+/ISH-)
  • Patients who have received prior chemotherapy in the metastatic setting or patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
  • Decision to newly initiate therapy of T-DXd or conventional chemotherapy according to the physicians choice per SmPC
  • Written and signed Informed Consent to participate in the study
  • Exclusion Criteria:
  • Pregnancy or breastfeeding
  • Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.
  • No specific exclusion criteria are defined, as patients will be treated according to the proposed indication statements in the SmPC.

About Daiichi Sankyo Europe, Gmbh, A Daiichi Sankyo Company

Daiichi Sankyo Europe GmbH, a subsidiary of Daiichi Sankyo Company, is a leading global pharmaceutical organization dedicated to the research, development, and commercialization of innovative medicines. With a strong focus on addressing unmet medical needs, the company leverages its expertise in pharmaceuticals and biotechnology to advance therapies in oncology, cardiovascular diseases, and other therapeutic areas. Committed to enhancing patient outcomes through scientific excellence and collaboration, Daiichi Sankyo Europe GmbH plays a pivotal role in driving clinical trials and bringing transformative treatments to market in Europe and beyond.

Locations

Brussels, , Belgium

Clermont Ferrand, , France

Rennes, , France

Madrid, , Spain

Paris, , France

Chieti, , Italy

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Santander, , Spain

Herlev, , Denmark

Limoges, , France

Paris, , France

Cordoba, , Spain

Créteil, , France

Wels, , Austria

Lille, , France

Troyes, , France

Zürich, , Switzerland

Rouen, , France

Brussels, , Belgium

Wien, , Austria

Suresnes, , France

Wien, , Austria

Lausanne, , Switzerland

Pavia, , Italy

Brasschaat, , Belgium

Graz, , Austria

Innsbruck, , Austria

Naestved, , Denmark

Reims, , France

La Laguna, , Spain

Rouen, , France

Aalst, , Belgium

Elche, , Spain

La Louviere, , Belgium

Lyon, , France

Antony, , France

Palma, , Spain

Aarhus N, , Denmark

Baden, , Switzerland

Caen, , France

Wien, , Austria

Poitiers, , France

Pau, , France

Valladolid, , Spain

Amiens, , France

Wiener Neustadt, , Austria

Dechy, , France

Bonheiden, , Belgium

Lyon, , France

Skien, , Norway

Liestal, , Switzerland

Arras, , France

Valenciennes, , France

Lille, , France

Ottignies, , Belgium

Niort, , France

Barakaldo, , Spain

Valladolid, , Spain

San Giovanni Rotondo, , Italy

St. Gallen, , Switzerland

Hasselt, , Belgium

Sion, , Switzerland

Cholet, , France

Jönköping, , Sweden

Barcelona, , Spain

Napoli, , Italy

Linz, , Austria

Vannes, , France

Montpellier, , France

Nice, , France

Novara, , Italy

Dijon, , France

Bordeaux, , France

Macerata, , Italy

Salzburg, , Austria

Klagenfurt Am Wörthersee, , Austria

Sabadell, , Spain

Vandœuvre Lès Nancy, , France

Alzira, , Spain

Le Puy En Velay, , France

León, , Spain

Taormina, , Italy

Galdakao, , Spain

Amiens, , France

Toulon, , France

Liège, , Belgium

Torino, , Italy

La Chaussee Saint Victor, , France

Bourg En Bresse, , France

Palencia, , Spain

Cáceres, , Spain

Valencia, , Spain

Bayonne, , France

Madrid, , Spain

Reims, , France

Sant Cugat Del Vallès, , Spain

Chalon Sur Saône, , France

Madrid, , Spain

Bayonne, , France

Vöcklabruck, , Austria

Namur, , Belgium

Bilbao, , Spain

Villeurbanne, , France

Sint Niklaas, , Belgium

Chambéry, , France

Padova, , Italy

Neuilly Sur Seine, , France

Sarcelles, , France

Gävle, , Sweden

Monza, , Italy

Chambray Lès Tours, , France

Rankweil, , Austria

Salzburg, , Austria

Brugge, , Belgium

Haine Saint Paul, , Belgium

Liege, , Belgium

Verviers, , Belgium

Aalborg, , Denmark

Sønderborg, , Denmark

Avignon, , France

Besançon, , France

Compiègne, , France

Fort De France Cedex, , France

Fréjus, , France

Grenoble, , France

La Tronche, , France

Le Mans, , France

Lille, , France

Metz, , France

Montivilliers, , France

Neuilly Sur Seine, , France

Nîmes Cedex 9, , France

Paris, , France

Paris, , France

Saint Cloud, , France

Saint Paul, , France

Sens Cédex, , France

Thionville, , France

Valence, , France

Alessandria, , Italy

Città Di Castello, , Italy

Empoli, , Italy

Lecco, , Italy

Legnago, , Italy

Meldola, , Italy

Palermo, , Italy

Potenza, , Italy

Roma, , Italy

Roma, , Italy

Salerno, , Italy

Torino, , Italy

Udine, , Italy

Varese, , Italy

Tromsø, , Norway

Albacete, , Spain

Cádiz, , Spain

Granada, , Spain

Lugo, , Spain

Murcia, , Spain

Oviedo, , Spain

Palma De Mallorca, , Spain

Pontevedra, , Spain

Reus, , Spain

Vigo Pontevedra, , Spain

Stockholm, , Sweden

Stockholm, , Sweden

Västerås, , Sweden

örebro, , Sweden

Frauenfeld, , Switzerland

Fribourg, , Switzerland

Genève, , Switzerland

Zürich, , Switzerland

Jaén, , Spain

Leoben, , Austria

Auderghem, , Belgium

Hillerød, , Denmark

Levallois Perret, , France

Lecce, , Italy

Legnano, , Italy

Modena, , Italy

Palermo, , Italy

Pisa, , Italy

Reggio Calabria, , Italy

Reggio Emilia, , Italy

Sassari, , Italy

Treviso, , Italy

Bodø, , Norway

Drammen, , Norway

Kristiansand, , Norway

Logroño, , Spain

Eskilstuna, , Sweden

Sundsvall, , Sweden

La Chaux De Fonds, , Switzerland

Lausanne, , Switzerland

Umeå, , Sweden

Patients applied

0 patients applied

Trial Officials

Global Team Leader

Study Director

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported