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Recruiting Observational

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

NCT05573893 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2023-09-12
Last updated
2026-09-11

Condition(s) studied

Breast NeoplasmsBreast CancerNeoplasm Metastasis

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Real-world Time To Next Treatment (rwTTNT1) — From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months
    rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy

Trial sites (109)

FacilityCityRegionStatus
Research Site Amberg Germany Withdrawn
Research Site Ansbach Germany Withdrawn
Research Site Apolda Germany Recruiting
Research Site Aschaffenburg Germany Recruiting
Research Site Augsburg Germany Recruiting
Research Site Augsburg Germany Recruiting
Research Site Bad Reichenhall Germany Recruiting
Research Site Baden-Baden Germany Recruiting
Research Site Balingen Germany Recruiting
Research Site Bamberg Germany Recruiting
Research Site Berlin Germany Recruiting
Research Site Berlin Germany Recruiting
Research Site Berlin Germany Recruiting
Research Site Berlin Germany Recruiting
Research Site Berlin Germany Recruiting
Research Site Bielefeld Germany Recruiting
Research Site Bonn Germany Recruiting
Research Site Brandenburg an der Havel Germany Recruiting
Research Site Braunschweig Germany Recruiting
Research Site Bremen Germany Recruiting
Research Site Bremerhaven Germany Recruiting
Research Site Coburg Germany Recruiting
Research Site Dessau Germany Recruiting
Research Site Donauwörth Germany Recruiting
Research Site Dortmund Germany Recruiting
Research Site Dresden Germany Recruiting
Research Site Dresden Germany Recruiting
Research Site Düsseldorf Germany Recruiting
Research Site Eggenfelden Germany Recruiting
Research Site Erfurt Germany Withdrawn
Research Site Essen Germany Recruiting
Research Site Filderstadt - Bonlanden Germany Recruiting
Research Site Frankfurt Germany Recruiting
Research Site Freudenstadt Germany Recruiting
Research Site Fürstenfeldbruck Germany Recruiting
Research Site Fürstenwalde Germany Recruiting
Research Site Gerlingen Germany Recruiting
Research Site Giessen Germany Recruiting
Research Site Halle Germany Recruiting
Research Site Hamburg Germany Recruiting

+ 69 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05573893 on ClinicalTrials.gov ↗ ← All trials in Germany