Clinical trial · Observational
Hemostatic Profiles of Endocrine Therapies for Breast Cancer
Hemostatic Profiles Associated With Use of Aromatase Inhibitors and Tamoxifen in Women With Breast Cancer : a Prospective Cohort Study
NCT03381963CI-TRIAL-00044582HEMOBREASTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Aromatase inhibitors
- label
- Tamoxifen
Primary outcomes (1)
- measure
- Change in thrombin generation, including APC sensitivity ratio
- timeFrame
- three months
Secondary outcomes (2)
- measure
- Change in levels of coagulation factors
- timeFrame
- three months
- description
- 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
- measure
- Change in fibrinolytic time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBlondon 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. PMID 35086148