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

Study Overview
=================
Brief 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 unresectable or metastatic breast cancer (BC) and in patients with documented HER2-low unresectable or metastatic 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 unresectable or metastatic BC receiving T-DXd for 2L treatment or patients with documented HER2-low 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 cohort.

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

Conditions
-----------------
Breast Neoplasms, Breast Cancer, Neoplasm Metastasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥ 18 years old Patients with pathologically documented breast cancer that: is unresectable or metastatic has confirmed HER2+ or HER2-low tumor status by local pathology was previously treated with one anti-HER2 directed therapy if the tumor is HER2+ 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 as second line treatment if the tumor is HER2+ or scheduled for T-DXd treatment if the tumor is HER2 low* Patient is able to read and understand either German or English Signed written informed consent *The prescription of the medicinal products are clearly separated from the decision to include the patient in this NIS. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Cohort 1 containing patients with documented HER2-positive unresectable or metastatic BC receiving T-DXd for 2L treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice. | |
| Cohort 2<br>Cohort 2 containing patients with documented HER2-low unresectable or metastatic BC receiving T DXd treatment in line with the applicable summary of product characteristics (SmPC) within routine clinical practice. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Real-world Time To Next Treatment (rwTTNT1) | rwTTNT1 is defined as the time from T-DXd initiation to initiation of subsequent therapy | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HRQoL based on FACT-B questionnaire at 6 months after baseline | To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-B questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQoL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS). FACT-B will be collected electronically at time points synchronized with clinic visits during the study. | 6 months | 
| Change in HRQoL based on FACT-G questionnaire at 6 months after baseline | To evaluate patient-reported outcomes (PROs)/ health-related quality of life (HRQoL) based on FACT-G questionnaire at 6 months after baseline. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure four domains of HRQoL in cancer patients: Physical, social, emotional, and functional well-being. FACT-G will be collected electronically at time points synchronized with clinic visits during the study. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trastuzumab-Deruxtecan,, Human epidermal growth factor receptor 2 Positive Breast Cancer,, Human epidermal growth factor receptor 2 Low Breast Cancer,