Informations générales (source: ClinicalTrials.gov)
A Prospective, Non-interventional Study (NIS) With Trastuzumab Deruxtecan For Patients With HER2-(Ultra)Low Expressing Unresectable and/or Metastatic Breast Cancer Accompanied By a Disease Registry of Patients Treated With Conventional Chemotherapy (DESTINY Breast Respond HER2-(Ultra)Low Europe)
Observational
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (Voir sur ClinicalTrials)
octobre 2023
décembre 2030
30 juin 2026
Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult
patients with unresectable or metastatic HER2-low breast cancer who have received prior
chemotherapy in the metastatic setting or developed disease recurrence during or within 6
months of completing adjuvant chemotherapy.
Based on the extended therapeutic indication of Trastuzumab deruxtecan (Enhertu®), a new
patient population will be enrolled, comprising adult patients with unresectable or
metastatic HR-positive, HER2-low, or HER2-(ultra)low breast cancer who have received at
least one endocrine therapy in the metastatic setting and are not considered suitable for
endocrine therapy as the next line of treatment.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:23 | Contact (sur clinicalTrials) | |||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:12:05 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Asmahane BENMAZIANE TEILLET | 27/07/2026 07:37:52 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 07/03/2025 14:58:34 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de Sens - 89108 - Sens Cédex - France | Principal Investigator | Contact (sur clinicalTrials) | |||
| CHU Martinique - 97261 - Fort De France Cedex - France | Principal Investigator | Contact (sur clinicalTrials) | |||
Critères
Tous
Study Group 1 and Study Group 2
- Adult patient (age ≥ 18 years) with histological or cytological confirmed diagnosis
of unresectable and/or mBC
- 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
Study Group 1
- 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
Study Group 2:
- Documented HR+ status
- Documented HER2-low status (IHC1+ or IHC2+/ISH-) or HER2-ultralow (defined as IHC 0
with membrane staining [IHC > 0 to <1+]) status
- Patients who have received at least one endocrine therapy in the metastatic setting
- Patients who have NOT received prior chemotherapy in the metastatic setting
Exclusion Criteria:
Study Group 1 and Study Group 2
- 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 other specific exclusion criteria are defined, as patients will be treated according
to the proposed indication statements in the SmPC.