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

Recruiting now

Conditions studied: Breast Neoplasms, Breast Cancer, Neoplasm Metastasis

In brief

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).

Key facts

Study ID: NCT05573893
Run by: AstraZeneca
People needed: 800
Starts: 2023-09-12
Expected to finish: 2031-12-31
Last updated by the study team: 2026-07-10

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults ≥ 18 years old
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.
Has documented radiologic progression (during or after most recent treatment)
Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment *
Patient is able to read and understand either German or English
Signed written informed consent
The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.

You may not qualify if…

Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)
Known hypersensitivity to T-DXd or any of the excipients of the drug
Pregnancy or breast feeding
Current or planned participation in an interventional clinical trial
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.

Where it is running

Research Site — Dresden, Germany (enrolling)
Research Site — Apolda, Germany (enrolling)
Research Site — Aschaffenburg, Germany (enrolling)
Research Site — Augsburg, Germany (enrolling)
Research Site — Augsburg, Germany (enrolling)
Research Site — Bad Reichenhall, Germany (enrolling)
Research Site — Baden-Baden, Germany (enrolling)
Research Site — Balingen, Germany (enrolling)
Research Site — Bamberg, Germany (enrolling)
Research Site — Berlin, Germany (enrolling)
Research Site — Berlin, Germany (enrolling)
Research Site — Berlin, Germany (enrolling)
Research Site — Berlin, Germany (enrolling)
Research Site — Berlin, Germany (enrolling)
Research Site — Bielefeld, Germany (enrolling)
Research Site — Bonn, Germany (enrolling)
Research Site — Brandenburg an der Havel, Germany (enrolling)
Research Site — Braunschweig, Germany (enrolling)
Research Site — Bremen, Germany (enrolling)
Research Site — Bremerhaven, Germany (enrolling)
Research Site — Coburg, Germany (enrolling)
Research Site — Dessau, Germany (enrolling)
Research Site — Donauwörth, Germany (enrolling)
Research Site — Dortmund, Germany (enrolling)
Research Site — Dresden, Germany (enrolling)

Full record on ClinicalTrials.gov

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