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.
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-)
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.
Study Group 1 will include 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. Study Group 2 will include adult patients with unresectable or metastatic HR +, HER2-low and HER2- ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment and have not received prior chemotherapy for advanced metastatic breast cancer.
Case-control
Prospective
Trastuzumab deruxtecan
DrugThis is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. Trastuzumab (T-DXd) to be administered according to the SmPC. Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.
Real World Time to Next Treatment (rwTTNT1) in Participants With Unresectable and/or Metastatic Breast Cancer
Type of Treatment Patterns in Participants With Unresectable and/or Metastatic Breast Cancer
Number of Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only)
Number of Participants Receiving Prophylactic and Reactive Treatment Management for Physician-reported Safety Events of Interest in Participants With Unresectable and/or Metastatic Breast Cancer (T-DXd only)
Real World Time to Permanent Treatment Discontinuation (rwTTD1) in Participants With Unresectable and/or Metastatic Breast Cancer
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