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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatase inhibitors | |||
| Tamoxifen |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in thrombin generation, including APC sensitivity ratio | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in levels of coagulation factors | 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 | three months |
| Change in fibrinolytic time |
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Inclusion Criteria: adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy
Exclusion Criteria:
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Women with a new diagnosis of non-metastatic breast cancer and a planned adjuvant endocrine therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35086148 | Derived | Blondon M, Bodmer A, Thouvenin L, Lecompte T, Righini M, Fontana P, Casini A. Differential impact of tamoxifen and aromatase inhibitors on thrombin generation: the prospective HEMOBREAST cohort. Blood Adv. 2022 May 10;6(9):2884-2892. doi: 10.1182/bloodadvances.2021006623. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| three months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |