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).
Female (both pre- and postmenopausal) or male patients
Age ≥18 years
Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III
Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction
Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0
History of suicide-related events
Current use of diuretics, antidepressants and/or phytoestrogens
Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine