Status:
COMPLETED
Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy
Lead Sponsor:
Hellenic Breast Surgeons Society
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Brief Summary
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...
Detailed Description
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 endocrin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT00814034
Start Date
February 1 2008
End Date
December 1 2011
Last Update
September 7 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hellenic Breast Surgeons Society
Athens, Attica, Greece, 11523
2
Hellenic Breast Surgeons Society
Athens, Greece, 11527