Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy

Study Overview
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Brief Summary
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The objective of the study is to monitor the changes of blood coagulation parameters in postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5 years. The values of the standard coagulation parameters throughout the study will be compared with the baseline values.

Detailed Description
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Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently discontinued for other reasons. The choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential option has been decided) is left at the discretion of the participating site. Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or radiotherapy. Percentage change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of treatment. The blood coagulation parameters which will be measured are fibrinogen, prothrombin time (PT) and activated partial thromboplastin time (aPTT).

Official Title
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An Observational, Prospective Cohort Study, on Blood Coagulation Parameters in Postmenopausal Patients With Operable Breast Cancer Who Are Treated as Per Standard Practice With Adjuvant Hormonal Therapy for a Total of 5 Years

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal status. ER and/or PgR status positive. Adjuvant hormonal treatment for 5 years according to standard practice has been decided by the treating physician. Values within normal limits for the blood coagulation parameters at baseline visit. Accessible for follow-up for the duration of the trial. Written informed consent. Exclusion Criteria: Both ER and PgR negative primary tumor. Evidence of distant metastases (M1) Neo-adjuvant hormonotherapy. Chronic use of oral anticoagulants such as warfarin or acenocoumarol. Psychiatric disorders preventing proper informed consent. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal squamous cell carcinoma of the skin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1:Tamoxifen<br> | |
| 2:Steroidal Aromatase Inhibitor<br> | |
| 3:Non-steroidal Aromatase Inhibitor<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change (%) from baseline of the blood coagulation parameters (fibrinogen, PT, aPTT) at 6, 12, 18, and 24 months of treatment. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatase Inhibitors, Coagulation parameters, Tamoxifen