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

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Breast Cancer; Diabetes

Treatments: Device: FreeStyle Libre Pro

Study type: Interventional

Funder types: Other

Identifiers

NCT05107388

2021/609

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Continuous interstitial glucose measurements

Experimental group

Description:

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

Treatment:

Device: FreeStyle Libre Pro