Follows patients with HER2-low breast cancer treated with trastuzumab deruxtecan
Observes adults with advanced HER2-low breast cancer receiving trastuzumab deruxtecan, a targeted drug.
Plain-language title generated from the registry record
Registry title: DESTINY Breast Respond HER2-(Ultra)Low Europe
Key facts
- Where
- Alcabideche, Lisboa, Amadora, Lisboa, Braga, Lisbon, Loures, Porto, and Vila Real, PortugalSee the 12 sites
Where in Portugal
- Hospital de CascaisAlcabideche, Lisboa, PortugalNo longer taking part
- ULS Amadora SintraAmadora, Lisboa, PortugalNo longer taking part
- ULS BragaBraga, PortugalNo longer taking part
- Dra. Berta SousaLisbon, PortugalNo longer taking part
- Hospital da Luz LisboaLisbon, PortugalNo longer taking part
- IPO LisboaLisbon, PortugalNo longer taking part
- ULS Santa MariaLisbon, PortugalNo longer taking part
- ULS Loures-Odivelas - Hospital Beatriz ÂngeloLoures, PortugalNo longer taking part
- Instituto Português de Oncologia do Porto Francisco GentilPorto, PortugalNo longer taking part
- ULS MatosinhosPorto, PortugalNo longer taking part
- ULS Santo AntónioPorto, PortugalNo longer taking part
- ULS Trás-os-Montes e Alto DouroVila Real, PortugalNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
- Trial code
- NCT05945732
- Record updated
- 19 August 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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.