COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Hemostatic Profiles of Endocrine Therapies for Breast Cancer (HEMOBREAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03381963
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : April 9, 2020
Information provided by (Responsible Party):
Marc Blondon, University Hospital, Geneva

Brief Summary:
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).

Condition or disease
Breast Neoplasms Venous Thromboembolism

Detailed Description:
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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hemostatic Profiles Associated With Use of Aromatase Inhibitors and Tamoxifen in Women With Breast Cancer : a Prospective Cohort Study
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Aromatase inhibitors

Primary Outcome Measures :
  1. Change in thrombin generation, including APC sensitivity ratio [ Time Frame: three months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with a new diagnosis of non-metastatic breast cancer and a planned adjuvant endocrine therapy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03381963

Layout table for location information
Geneva University Hospitals
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Layout table for additonal information
Responsible Party: Marc Blondon, Principal Investigator, University Hospital, Geneva Identifier: NCT03381963    
Other Study ID Numbers: 2016-119
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marc Blondon, University Hospital, Geneva:
aromatase inhibitors
breast cancer
venous thromboembolism
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Venous Thromboembolism
Neoplasms by Site
Breast Diseases
Skin Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases