Hemostatic Profiles of Endocrine Therapies for Breast Cancer
- Conditions
- Venous ThromboembolismBreast Neoplasms
- Registration Number
- NCT03381963
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
The aim of this prospective cohort study is to evaluate the modifications of the biological hemostatic profile associated with the use of endocrine therapy in women with breast cancer (tamoxifen or aromatase inhibitors).
- Detailed Description
In this cohort study, women with breast cancer and an indication for endocrine therapy will be prospectively enrolled. At the 1st visit (before the start of endocrine therapy (tamoxifen or aromatase inhibitor)) and at the 2nd visit (at \~3 months after the start of treatment), demographical / clinical data and blood samples will be collected. We will evaluate the hemostatic biological profiles associated with the use of endocrine therapy by comparing hemostatic biomarkers before and during its use.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy
- lack of consent
- planned chemotherapy
- personal history of venous thromboembolism
- ongoing anticoagulant treatment
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in thrombin generation, including APC sensitivity ratio three months
- Secondary Outcome Measures
Name Time Method Change in fibrinolytic time three months Change in levels of coagulation factors three months Levels of the following coagulation factors will be measured and compared before and after use of endocrine treatments: antithrombin, protein C, protein S, D-dimer, fibrinogen, F VII, F VIII
Trial Locations
- Locations (1)
Geneva University Hospitals
🇨🇭Geneva, Switzerland