About this trial

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.

Eligibility criteria

Qualifiers

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

Documented HER2-low status (IHC1+, IHC2+/ISH-)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Trastuzumab deruxtecan

Treatment groups

2,295 Participants
are divided into 2 treatment groups

Locations

211
Austria
Medizinische Universität Graz8036, Graz Austria
Medizinische Universität Graz8036, Graz Austria
Medizinische Universität Innsbruck6020, Innsbruck Austria
Klinikum Klagenfurt am Wörthersee9020, Klagenfurt Austria

Sponsors and collaborators

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Lead sponsor