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
18 Years
80 Years
Female
Breast Cancer
Trial Information
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
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).
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Percentage change (%) from baseline of the blood coagulation parameters (fibrinogen, PT, aPTT) at 6, 12, 18, and 24 months of treatment.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Christos Markopoulos, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hellenic Breast Surgeons Society
Authority:
Greece: National Organization of Medicines
Study ID:
COPA-HBSS0801
NCT ID:
NCT00814034
Start Date:
February 2008
Completion Date:
December 2011
Related Keywords:
- Breast Cancer
- Aromatase Inhibitors
- Coagulation parameters
- Tamoxifen
- Breast Neoplasms
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