Clinical trial NCT06505018: Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
Official title: A Randomized Phase III Study Comparing the Digital Telemonitoring Platform "CUREETY TECHCARE" to Usual Standard of Care in Patients With Triple Negative Metastatic Breast Cancer Initiating a First-line Systemic Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Triple-Negative Breast Carcinoma
Keywords: Telemonitoring
Triple Negative Breast Cancer
Cureety
Adverse events
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Cureety
First posted: 2024-07-17
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to assess whether adding telemonitoring (the digital telemonitoring platform "CUREETY TECHCARE"), to standard care, will benefit patients with previously untreated metastatic triple-negative breast cancer starting first-line cancer therapy.

The main questions it aims to answer are:

* Is patient quality of life improved by using the telemonitoring platform?
* Are patients hospitalized less frequently when using the telemonitoring platform?
* Is the patient overall survival improved by telemonitoring ?

Researchers will compare data from patients using telemonitoring while receiving standard care with data from patients receiving only standard care.

Participants using telemonitoring will answer questions about their symptoms on the platform. The platform will analyze these symptoms, assess the patient's general condition and provide advice accordingly. Medical staff will also access the platform to monitor the patient's general condition and contact them if necessary.


Eligibility criteria: Inclusion Criteria:

* Signed a written informed consent form prior to participate in the study. Note: In case of physical incapacitation, a trusted representative of their choice, which is not the Investigator or sponsor, can sign on the behalf of the patients
* Patients ≥18 years of age.
* Patient with histologically documented metastatic triple negative breast cancer (ER (Oestrogen receptor) and PR (Progesterone receptor) \<10%, Her2 negative status).
* Life expectancy \> 6 months as per investigator estimate.
* Patient initiating a marketed authorized first-line systemic treatment in the metastatic setting.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.
* Patient having completed the EORTC QLQ-C30 and EORTC QLQ-BR45 at baseline (response to questions 29 and 30 of EORTC QLQ-C30 at baseline are mandatory)
* Affiliated to the social security system or equivalent health insurance.
* Patient able and willing to complete web-based self-reported questionnaires, from initiation of first-line treatment and for the duration of the study (over multiple treatment lines)
* Patient has access to a computer, tablet, or smartphone connected to the Internet.

Exclusion Criteria:

* Participation in another clinical trial using telemonitoring.
* Physical or psychological incapacity of the patient to use the digital telemonitoring Cureety Techcare, according to the investigator's discretion.
* Patient deprived of their liberty or under protective custody or guardianship.

Primary outcomes:
measure: Time to definitive Health-Related Quality of life score Deterioration
timeFrame: At baseline then every 3 months, up to 24 months
measure: Hospitalization-free survival
timeFrame: From randomization to death from any cause, up to 24 months
measure: Overall survival
timeFrame: From randomization to death from any cause, up to 24 months after last inclusion
Secondary outcomes:
measure: Time-to-treatment failure
timeFrame: From randomization to treatment discontinuation, up to 24 months
measure: Toxicity-free survival
timeFrame: From randomization until the first event, up to 24 months
measure: Time to clinical deterioration
timeFrame: From randomization, to the date of the first clinical deterioration, up to 24 months
measure: Number of treatment lines
timeFrame: Throughout study completion, up to 24 months
measure: Incidence of Adverse Events
timeFrame: Throughout study completion, up to 24 months
measure: Quality of life questionnaire - Core 30 (QLQ-C30)
timeFrame: At baseline then every 3 weeks, up to 24 months
measure: Quality of Life Questionnaire - Breast cancer module (QLQ-BR45)
timeFrame: At baseline then every 3 weeks, up to 24 months
measure: Treatment compliance and extent of exposure
timeFrame: Throughout study completion, up to 24 months
measure: Compliance with the use of Cureety digital telemonitoring
timeFrame: Throughout study completion, up to 24 months
measure: Satisfaction with Cureety telemonitoring
timeFrame: 3 months after randomisation for the patients and 1 year after the site activation for medical team
measure: Patient's global satisfaction with care using the data of the EORTC OUT-PATSAT-35
timeFrame: 6 months after randomisation
measure: Socio-economic impact of digital telemonitoring
timeFrame: Throughout study completion, up to 24 months after randomization
Other outcomes:
Locations:
city: Arras
country: France
facility: Institut de Cancérologie des Hauts-de-France (ICHF)
city: Auxerre
country: France
facility: Centre Hospitalier d'Auxerre
city: Avignon
country: France
facility: Sainte Catherine - Institut du Cancer Avignon Provence
city: Bayeux
country: France
facility: CH Aunay-Bayeux
city: Beauvais
country: France
facility: Centre Hospitalier Simone Veil de Beauvais
city: Beuvry
country: France
facility: ICHF - Centre Pierre Curie
city: Blois
country: France
facility: Hôpital Simone Veil de Blois
city: Bordeaux
country: France
facility: Polyclinique bordeaux nord
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Fleyriat
city: Caen
country: France
facility: Centre de Cancérologie Privé de Caen Maurice Tubiana
city: Caen
country: France
facility: Centre Francois Baclesse
city: Carcassonne
country: France
facility: Centre hospitalier de Carcasonne
city: Chambray-lès-Tours
country: France
facility: Recherche Oncologie Clinqiue 37 (ROC 37)
city: Cholet
country: France
facility: CH de Cholet
city: Colmar
country: France
facility: CH Colmar
city: Creil
country: France
facility: Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Dunkerque
country: France
facility: Institut Andrée Dutreix
city: Fréjus
country: France
facility: Centre Hospitalier Intercommunal de Fréjus Saint Raphael
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: La Rochelle
country: France
facility: Groupe Hospitalier de La Rochelle-Ré-Aunis
city: La Réunion
country: France
facility: CHU de la réunion
city: La Réunion
country: France
facility: Clinique Sainte Clotilde
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Le Coudray
country: France
facility: Centre Hospitalier Louis Pasteur
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
city: Lorient
country: France
facility: GHBS Lorient
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Clinique de la Sauvegarde
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Mont-de-Marsan
country: France
facility: CHI de Mont-de-Marsan et du Pays des Sources
city: Montpellier
country: France
facility: Centre de Cancérologie du Grand Montpellier
city: Nantes
country: France
facility: Hôpital Privé du Confluent
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise-Pare Hartmann
city: Neuilly-sur-Seine
country: France
facility: Hôpital Américain de PARIS
city: Nîmes
country: France
facility: CHU de Nimes
city: Orléans
country: France
facility: CHR Orleans
city: Osny
country: France
facility: CHP Sainte-Marie
city: Paris
country: France
facility: Diaconesses Croix Saint-Simon Hospital Complex
city: Pau
country: France
facility: Centre hospitalier de Pau
city: Plérin
country: France
facility: CARIO - Hopital Privé des Cotes d'Armor
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims
country: France
facility: Institut Godinot
city: Rouen
country: France
facility: Clinique Mathilde - Les Hôpitaux Privés Rouennais
city: Saint-Mandé
country: France
facility: Hia Begin
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
city: Tours
country: France
facility: CHU de Tours
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
city: Épagny
country: France
facility: CH Annecy Genevois
Study officials:
affiliation: Armorican Centre for Radiotherapy, Medical Imaging and Oncology, CARIO, Plérin
name: Jérôme MARTIN-BABAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: François Baclesse Center, Caen
name: Florence JOLY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University hospital of Nîmes
name: Frédéric FITENI, MD
role: PRINCIPAL_INVESTIGATOR
References: