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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:Tamoxifen | |||
| 2:Steroidal Aromatase Inhibitor | |||
| 3:Non-steroidal Aromatase Inhibitor |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Postmenopausal, ER and/or PgR positive breast cancer patients eligible for adjuvant hormonal treatment (HT), who are admitted for treatment and follow-up at the participating sites, will be enrolled in the trial. 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.
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| Name | Affiliation | Role |
|---|---|---|
| Christos Markopoulos, MD | Hellenic Breast Surgeons Society | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Breast Surgeons Society | Athens | Attica | 11523 | Greece | ||
| Hellenic Breast Surgeons Society |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Athens |
| 11527 |
| Greece |
| D017437 |
| Skin and Connective Tissue Diseases |