Clinical Trial

Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer

Not Yet Recruiting Phase 3
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Summary
This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+/HER2- early breast cancer with joint, muscle and/or bone pain caused by the endocrine therapy. The purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and/or bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-05-06; most recent amendment 2024-11-04.
Trial Details
NCT Number NCT06407401
Lead Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Conditions ER+ Breast Cancer, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Drug-Related Side Effects and Adverse Reactions, Musculoskeletal Pain
Enrollment 399 participants
Start Date 2024-12
Primary Completion 2028-04-18 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-05