Recruiting NCT05573893

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

— Observational Breast Neoplasms Breast Cancer Neoplasm Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Breast Neoplasms, Breast Cancer, Neoplasm Metastasis. Basic parameters: 18 years — 130 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Germany
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

Eligible participants will be those patients with documented HER2-positive, HER2-low or HER2-ultralow unresectable or metastatic BC receiving T-DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice.

All diagnostic and treatment procedures including visit frequency are at the discretion of the treating physician and not defined by the protocol. T-DXd treatment is considered as a selection criteria. Patients will be informed about use of digital healthcare application (DiGA).

Approximately 800 eligible participants will be enrolled which includes 400 patients in the HER2-positive cohort and 400 patients in the HER2-low/ HER2-ultralow cohort.

Primary outcome measures

Real-world Time To Next Treatment (rwTTNT1) [Time frame: From first dose of T-DXd until initiation of subsequent therapy or death of any cause, whichever came first, assessed up to 60 months]

Secondary outcome measures (2)

Change in HRQoL based on FACT-B questionnaire at 6 months after baseline [Time frame: 6 months]
Change in HRQoL based on FACT-G questionnaire at 6 months after baseline [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

Germany · 108 centers

Research Site — Amberg
Research Site — Ansbach
Research Site — Apolda
Research Site — Aschaffenburg
Research Site — Augsburg
Research Site — Augsburg
Research Site — Bad Reichenhall
Research Site — Baden-Baden
… and 100 more centers

Identifiers

NCT: NCT05573893 · D9673R00028

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗