Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
ALTERNATIVE
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
2 other identifiers
interventional
472
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
July 17, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 2, 2028
September 2, 2025
August 1, 2025
2.1 years
July 10, 2024
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Time to definitive Health-Related Quality of life score Deterioration
The time to definitive Health-Related Quality of life score Deterioration is the length of time from randomization to the first deterioration of ≥ 10 points out of 100 or ≥2 points out of 14 in the global health status (GHS) score (items 29 and 30 of the QLQ-C30) compared with the baseline, assuming no improvement of at least 2 points in the GHS score compared with the baseline has occurred. The responses to the items 29-30 of the QLQ-C30 will be scored using the QLQ scoring manual. These 2 items have possible values ranging from 1 (very bad) to 7 (excellent) corresponding to a sum from 2 to 14 points. After conversion to percentages, the GHS will range from 0% to 100%. The higher the value, the better the quality of life.
At baseline then every 3 months, up to 24 months
Hospitalization-free survival
Hospitalization-free survival is the length of time from randomization during which patients enrolled in the study are not hospitalized and remain alive.
From randomization to death from any cause, up to 24 months
Overall survival
overall survival is the length of time from randomization during which patients enrolled in the study remain alive.
From randomization to death from any cause, up to 24 months after last inclusion
Secondary Outcomes (12)
Time-to-treatment failure
From randomization to treatment discontinuation, up to 24 months
Toxicity-free survival
From randomization until the first event, up to 24 months
Time to clinical deterioration
From randomization, to the date of the first clinical deterioration, up to 24 months
Number of treatment lines
Throughout study completion, up to 24 months
Incidence of Adverse Events
Throughout study completion, up to 24 months
- +7 more secondary outcomes
Study Arms (2)
Telemonitoring group
EXPERIMENTALStandard of care with digital telemonitoring "Cureety TechCare". The telemonitoring will comprise weekly adverse event (AE) evaluations and their analyses by the "Cureety TechCare".
Standard-of-care group
NO INTERVENTIONInterventions
Each week, patients complete a questionnaire via the Cureety platform, specifically designed for the drug class or specific treatment being administered. Based on their responses, the Cureety TechCare algorithm classifies patients into one of four risk categories: "correct" (green), "compromised" (yellow), "state to be monitored" (orange), or "critical state" (red). (Note: the color code is not visible to the patient). The medical team uses the dashboard for daily patient monitoring and manages alerts related to the "clinical classification" of the patient's condition. The physician in charge of telemonitoring interprets the data, adjusts the treatment as needed, and provides supportive care during standard care consultations. Patients are also notified of alerts with tailored messages guiding them on the actions to take according to the category determined by the device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Institut de Cancérologie des Hauts-de-France (ICHF)
Arras, France
Centre Hospitalier d'Auxerre
Auxerre, France
Sainte Catherine - Institut du Cancer Avignon Provence
Avignon, France
CH Aunay-Bayeux
Bayeux, France
Centre Hospitalier Simone Veil de Beauvais
Beauvais, France
ICHF - Centre Pierre Curie
Beuvry, France
Hôpital Simone Veil de Blois
Blois, France
Polyclinique bordeaux nord
Bordeaux, France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, France
Centre de Cancérologie Privé de Caen Maurice Tubiana
Caen, France
Centre Francois Baclesse
Caen, France
Centre hospitalier de Carcasonne
Carcassonne, France
Recherche Oncologie Clinqiue 37 (ROC 37)
Chambray-lès-Tours, France
CH de Cholet
Cholet, France
CH Colmar
Colmar, France
Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
Creil, France
Centre Georges François Leclerc
Dijon, France
Institut Andrée Dutreix
Dunkirk, France
CH Annecy Genevois
Épagny, France
Centre Hospitalier Intercommunal de Fréjus Saint Raphael
Fréjus, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
CHU de la réunion
La Réunion, France
Clinique Sainte Clotilde
La Réunion, France
Groupe Hospitalier de La Rochelle-Ré-Aunis
La Rochelle, France
CHU Grenoble Alpes
La Tronche, France
Centre Hospitalier Louis Pasteur
Le Coudray, France
Centre Hospitalier Le Mans
Le Mans, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
GHBS Lorient
Lorient, France
Centre Leon Berard
Lyon, France
Clinique de la Sauvegarde
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHI de Mont-de-Marsan et du Pays des Sources
Mont-de-Marsan, France
Centre de Cancérologie du Grand Montpellier
Montpellier, France
Hôpital Privé du Confluent
Nantes, France
Clinique Ambroise-Pare Hartmann
Neuilly-sur-Seine, France
Hôpital Américain de PARIS
Neuilly-sur-Seine, France
CHU de Nimes
Nîmes, France
CHR Orleans
Orléans, France
CHP Sainte-Marie
Osny, France
Diaconesses Croix Saint-Simon Hospital Complex
Paris, France
Centre hospitalier de Pau
Pau, France
CARIO - Hopital Privé des Cotes d'Armor
Plérin, France
CHU de Poitiers
Poitiers, France
Institut Godinot
Reims, France
Clinique Mathilde - Les Hôpitaux Privés Rouennais
Rouen, France
CHU de Saint-Etienne
Saint-Etienne, France
Hia Begin
Saint-Mandé, France
CHU de Tours
Tours, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme MARTIN-BABAU, MD
Armorican Centre for Radiotherapy, Medical Imaging and Oncology, CARIO, Plérin
- PRINCIPAL INVESTIGATOR
Florence JOLY, MD
François Baclesse Center, Caen
- PRINCIPAL INVESTIGATOR
Frédéric FITENI, MD
University hospital of Nîmes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2024
First Posted
July 17, 2024
Study Start
July 25, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 2, 2028
Last Updated
September 2, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.