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PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of…

ClinicalTrials.gov IDNCT05573893
PhaseNot Applicable
Enrollment800
SponsorAstraZeneca
Age18 Years – 130 Years
SexALL
I'm interested View official listing

Conditions studied

Breast Neoplasms, Breast Cancer, Neoplasm Metastasis

About this study

This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).

Primary outcomes

Eligibility information

Inclusion Criteria: 1. Adults ≥ 18 years old 2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that: * is unresectable or metastatic * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low. 3. Has documented radiologic progression (during or after most recent treatment) 4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \* 5. Patient is able to read and understand either German or English 6. Signed written informed consent * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS. Exclusion Criteria: 1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date) 2. Known hypersensitivity to T-DXd or any of the excipients of the drug 3. Pregnancy or breast feeding 4. Current or planned participation in an interventional clinical trial 5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC Patients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.

Study locations

Showing 10 of 109 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.