Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

NCT ID: NCT05107388

Last Updated: 2021-11-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2024-03-31

Brief Summary

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The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

Detailed Description

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AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.

Conditions

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Breast Cancer Diabetes

Keywords

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Breast Cancer, Alpelisib, hyperglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Continuous interstitial glucose measurements

Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro

Group Type EXPERIMENTAL

FreeStyle Libre Pro

Intervention Type DEVICE

Measurements of interstitial glucose variations with FreeStyle Libre Pro

Interventions

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FreeStyle Libre Pro

Measurements of interstitial glucose variations with FreeStyle Libre Pro

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Women suffering breast cancer and eligible to treatment with Alpelisib
2. Age ≥18 years
3. Menopausal women (for at least 24 months)
4. Informed Consent Form signed

Exclusion Criteria

1. Men
2. Pregnant ou child-bearing potential women
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sophie BOROT, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Locations

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CHU de Besançon

Besançon, , France

Site Status

Countries

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France

Central Contacts

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Fatimata SARR SALL, PhD

Role: CONTACT

Phone: 033381219449

Email: [email protected]

Facility Contacts

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Fatimata SARR SALL, PhD

Role: primary

Other Identifiers

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2021/609

Identifier Type: -

Identifier Source: org_study_id