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Challenges and Opportunities for Real-World Evidence in Metastatic Luminal Breast Cancer
Diana Lüftner1, Andreas D Hartkopf2, Michael P Lux3,4
1Department of Hematology, Oncology and Tumor Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Background:
The therapeutic armamentarium for patients with metastatic breast cancer is becoming more and more specific. Recommendations from clinical trials are not available for all treatment situations and patient subgroups, and it is therefore important to collect real-world data.
Summary:
To develop recommendations for up-to-date treatments and participation in clinical trials for patients with metastatic breast cancer, the Prospective Academic Translational Research PRAEGNANT Network was established to optimize the quality of oncological care in the advanced therapeutic setting. The main aim of PRAEGNANT is to systematically record medical care for patients with metastatic breast cancer in the real-life setting, including the outcome and side effects of different treatment strategies, to monitor quality-of-life changes during therapy, to identify patients eligible for participation in clinical studies, and to allow targeted therapies based on the molecular structures of breast carcinomas.
Key Messages:
This article describes the PRAEGNANT network and sheds light on the question of whether the various end points from clinical trials can be transferred to the real-world treatment situation.
Insights
The Prospective Academic Translational Research PRAEGNANT Network collects real-world data for metastatic breast cancer patients. This network aims to improve oncological care by tracking treatments, outcomes, and side effects in real-life settings.
Area of Science:
- Oncology
- Translational Research
- Real-World Data Analysis
Background:
- Therapeutic options for metastatic breast cancer are increasingly specialized.
- Clinical trial recommendations do not cover all treatment scenarios or patient subgroups.
- Real-world data collection is crucial for comprehensive treatment guidance.
Purpose of the Study:
- Establish the Prospective Academic Translational Research PRAEGNANT Network to optimize oncological care for metastatic breast cancer.
- Systematically record real-life medical care, treatment outcomes, and side effects.
- Monitor quality-of-life changes and identify patients for clinical studies.
Main Methods:
- Establishment of the PRAEGNANT network for systematic data collection.
- Recording of medical care, treatment outcomes, and side effects in a real-life setting.
- Monitoring quality-of-life and identifying patients for clinical trials based on molecular tumor characteristics.
Main Results:
- The PRAEGNANT network facilitates the systematic recording of real-world data for metastatic breast cancer patients.
- Data collected includes treatment strategies, outcomes, side effects, and quality-of-life.
- The network aims to enable targeted therapies based on molecular tumor profiles.
Conclusions:
- The PRAEGNANT network is designed to enhance oncological care for metastatic breast cancer patients.
- It addresses the need for real-world data to complement clinical trial findings.
- The network evaluates the transferability of clinical trial endpoints to real-world treatment scenarios.
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