Breast Neoplasms, Venous Thromboembolism
Conditions
Keywords
tamoxifen, aromatase inhibitors, breast cancer, venous thromboembolism
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.
Interventions
None listed
Sponsors
University Hospital, Geneva
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy
Exclusion criteria
* lack of consent * planned chemotherapy * personal history of venous thromboembolism * ongoing anticoagulant treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in thrombin generation, including APC sensitivity ratio | three months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in fibrinolytic time | three months | — |
Countries
Switzerland
Outcome results
None listed