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Completed

NCT Number: NCT03381963

Hemostatic Profiles of Endocrine Therapies for Breast Cancer

The aim of this prospective cohort study is to evaluate the modifications of the biological hemostatic profile associated with the use of endocrine therapy in women with breast cancer (tamoxifen or aromatase inhibitors).

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Key information

Conditions

Breast Neoplasms Breast Diseases Cardiovascular Diseases Embolism and Thrombosis Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, Switzerland

About this study

In this cohort study, women with breast cancer and an indication for endocrine therapy will be prospectively enrolled. At the 1st visit (before the start of endocrine therapy (tamoxifen or aromatase inhibitor)) and at the 2nd visit (at ~3 months after the start of treatment), demographical / clinical data and blood samples will be collected. We will evaluate the hemostatic biological profiles associated with the use of endocrine therapy by comparing hemostatic biomarkers before and during its use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

adult women with a diagnosis of non-metastatic breast cancer and an indication for adjuvant endocrine therapy

Exclusion criteria

  • lack of consent
  • planned chemotherapy
  • personal history of venous thromboembolism
  • ongoing anticoagulant treatment

Treatment and study plan

Primary outcomes

  1. Change in thrombin generation, including APC sensitivity ratio

    Time frame: three months

Secondary outcomes

  1. Change in levels of coagulation factors

    Time frame: three months

    Levels of the following coagulation factors will be measured and compared before and after use of endocrine treatments: antithrombin, protein C, protein S, D-dimer, fibrinogen, F VII, F VIII

  2. Change in fibrinolytic time

    Time frame: three months

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Official study title

Hemostatic Profiles Associated With Use of Aromatase Inhibitors and Tamoxifen in Women With Breast Cancer : a Prospective Cohort Study

Acronym: HEMOBREAST

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2017
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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