Hemostatic Profiles Associated With Use of Aromatase Inhibitors and Tamoxifen in Women With Breast Cancer : a Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Geneva
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in thrombin generation, including APC sensitivity ratio
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Change in thrombin generation, including APC sensitivity ratio
Time Frame: three months
Secondary Outcomes
- Change in fibrinolytic time(three months)
- Change in levels of coagulation factors(three months)
Investigators
Marc Blondon
Principal Investigator
University Hospital, Geneva