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

Recruiting

• Conditions: Breast Neoplasms; Breast Cancer; Neoplasm Metastasis

• Registration Number: NCT05573893
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-9-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Inclusion Criteria:<br><br> - Adults = 18 years old<br><br> - Patients with pathologically documented breast cancer that:<br><br> - is unresectable or metastatic<br><br> - has confirmed HER2+ or HER2-low tumor status by local pathology<br><br> - was previously treated with one anti-HER2 directed therapy if the tumor is HER2+ or<br><br> - was previously treated with prior chemotherapy in the metastatic setting or<br> developed disease recurrence during or within 6 months of completing adjuvant<br> chemotherapy if the tumor is HER2- low.<br><br> - Has documented radiologic progression (during or after most recent treatment)<br><br> - Patient is eligible for T-DXd treatment in line with the specifications mentioned in<br> the ENHERTU® SmPC and is scheduled for T-DXd as second line treatment if the tumor<br> is HER2+ or scheduled for T-DXd treatment if the tumor is HER2 low*<br><br> - Patient is able to read and understand either German or English<br><br> - Signed written informed consent *The prescription of the medicinal products are<br> clearly separated from the decision to include the patient in this NIS.<br><br>Exclusion Criteria:<br><br> - Known hypersensitivity to T-DXd or any of the excipients of the drug<br><br> - Pregnancy or breast feeding<br><br> - Current or planned participation in an interventional clinical trial<br><br> - Current or planned systemic treatment of any tumor other than unresectable or<br> metastatic BC

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world Time To Next Treatment (rwTTNT1)

Secondary Outcome Measures

Name	Time	Method
Change in HRQoL based on FACT-B questionnaire at 6 months after baseline;Change in HRQoL based on FACT-G questionnaire at 6 months after baseline