Prospective Non-interventional Study to Examine Patient Outcomes and Real-world Data in HER2-positive, HER2-low, or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan

What this Trial Is About

Researchers are evaluating patient-reported outcomes and real-world data on the use of trastuzumab deruxtecan T-DXd in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This observational study focuses on the effectiveness and safety of T-DXd as used in routine clinical practice in Germany, including how patients respond to the treatment over time. The study is non-interventional and involves patients receiving T-DXd according to approved guidelines. The study includes two groups one with patients having HER2-positive tumors and another with patients having HER2-low or HER2-ultralow tumors. All patients receive T-DXd treatment as recommended by the products summary of characteristics, and all medical decisions including treatment schedules are made by the treating physicians. Participants will also be informed about the use of a digital healthcare application DiGA to support their care. Participants will be observed for up to 60 months to track the time until the next treatment or death, whichever occurs first. Patient quality of life will be assessed six months after starting treatment using specific questionnaires FACT-B and FACT-G. Other data collected will include safety and efficacy outcomes reported during regular clinical visits. The study aims to enroll approximately 800 patients, with about 400 in each cohort, and will continue until the end of 2031.

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