Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00814034

Acronym

COPA

Enrollment

306

Registered

2008-12-23

Start date

2008-02-29

Completion date

2011-12-31

Last updated

2015-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Aromatase Inhibitors, Coagulation parameters, Tamoxifen

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 standard coagulation parameters throughout the study will be compared with the baseline values.

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 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Countries

Greece

Outcome results