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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.
 
ClinicalTrials.gov Identifier: NCT03381963
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Marc Blondon, University Hospital, Geneva

Study Description
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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.
Study Design
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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

Groups and Cohorts
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Group/Cohort
Aromatase inhibitors
Tamoxifen


Outcome Measures
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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 ]

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03381963


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
More Information
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Responsible Party: Marc Blondon, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov 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

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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:
tamoxifen
aromatase inhibitors
breast cancer
venous thromboembolism
Additional relevant MeSH terms:
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Breast Neoplasms
Thromboembolism
Venous Thromboembolism
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases