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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

Age: 18Years - 60YearsFEMALE
71 locations
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Actively Recruiting

Researchers are observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.

Age: 18Years - 130YearsAll Genders
109 locations