drugset / Trial / NCT06407401
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
Phase 3
Not yet recruiting
399 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
RandomizedParallel-groupOpen-labelSupportive care
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).
Timeline
- Start
- 2024-12
- Primary completion
- 2028-04-18
- Completion
- 2028-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 60 mg | Oral |
| Subject | Furosemide | Other / unclassified | 40 mg | Oral |