NCT05107388

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

October 25, 2021

Last Update Submit

October 25, 2021

Conditions

Breast CancerDiabetes

Keywords

Breast Cancer, Alpelisib, hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of hyperglycemia

    In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows: * if diabetes de novo: * capillar or interstitial fasting blood glucose ≥ 1,50 g/L, * OR postprandial interstitial glucose ≥ 2 g/L * OR glucose monitoring indicator ≥ 6,5% * if worsening pre-existing diabetes: * increased capillar or interstitial fasting blood glucose ≥ 0,50 g/L compared to average fasting blood glucose at J-3, J-2 and J-1 * AND postprandial interstitial glucose ≥ + 1,00 g/L compared to average fasting blood glucose at J-3, J-2 et J-1 OR average blood glucose ≥ +0,50 g/L

    Day 14

Study Arms (1)

Continuous interstitial glucose measurements

EXPERIMENTAL

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

Device: FreeStyle Libre Pro

Interventions

FreeStyle Libre ProDEVICE

Measurements of interstitial glucose variations with FreeStyle Libre Pro

Continuous interstitial glucose measurements

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Men
  • Pregnant ou child-bearing potential women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Breast NeoplasmsDiabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sophie BOROT, MD, PhD

    CHU de Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatimata SARR SALL, PhD

CONTACT

033381219449fatimata.sarr@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 4, 2021

Study Start

December 1, 2021

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

November 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)