Hemostatic Profiles of Endocrine Therapies for Breast Cancer

NCT ID: NCT03381963

Last Updated: 2020-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-02-28

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Breast Neoplasms Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aromatase inhibitors

No interventions assigned to this group

Tamoxifen

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* lack of consent
* planned chemotherapy
* personal history of venous thromboembolism
* ongoing anticoagulant treatment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Marc Blondon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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Blondon M, Bodmer A, Thouvenin L, Lecompte T, Righini M, Fontana P, Casini A. Differential impact of tamoxifen and aromatase inhibitors on thrombin generation: the prospective HEMOBREAST cohort. Blood Adv. 2022 May 10;6(9):2884-2892. doi: 10.1182/bloodadvances.2021006623.

Reference Type DERIVED
PMID: 35086148 (View on PubMed)

Other Identifiers

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2016-119

Identifier Type: -

Identifier Source: org_study_id

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