Hemostatic Profiles of Endocrine Therapies for Breast Cancer (HEMOBREAST)

April 7, 2020 updated by: Marc Blondon, University Hospital, Geneva

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

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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a new diagnosis of non-metastatic breast cancer and a planned adjuvant endocrine therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Aromatase inhibitors
Tamoxifen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in thrombin generation, including APC sensitivity ratio
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
three months
Change in fibrinolytic time
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

December 21, 2017

First Posted (Actual)

December 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-119

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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