ER positive HER2 negative breast cancer stages I-II
Conditions
Brief summary
Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 at month 3. • The skeletal scale score is computed based on the following four individual items from the EORTC QLQ-BR42 questionnaire Have you had problems with your joints? • Have you had stiffness in your joints? • Have you had pain in your joints? • Have you had aches or pains in your bones?
Detailed description
Discontinuation of endocrine therapy, Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 questionnaire at month 6, Change from baseline in Global health status/QoL scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months, Change from baseline in Emotional functioning scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months, Change from baseline Endocrine therapy symptoms scale according to EORTC-BR42 questionnaire at 3 and 6 months, Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting
Interventions
DRUGFUROSEMIDE
DRUGDULOXETINE
Sponsors
Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 at month 3. • The skeletal scale score is computed based on the following four individual items from the EORTC QLQ-BR42 questionnaire Have you had problems with your joints? • Have you had stiffness in your joints? • Have you had pain in your joints? • Have you had aches or pains in your bones? | — |
Secondary
| Measure | Time frame |
|---|---|
| Discontinuation of endocrine therapy, Change from baseline in the skeletal scale as assessed by the EORTC QLQ-BR42 questionnaire at month 6, Change from baseline in Global health status/QoL scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months, Change from baseline in Emotional functioning scale according to EORTC-QLQ-C30 questionnaire at 3 and 6 months, Change from baseline Endocrine therapy symptoms scale according to EORTC-BR42 questionnaire at 3 and 6 months, Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting | — |
Countries
Cyprus, France, Poland, Slovenia, Spain
Outcome results
None listed