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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Triple-Negative Breast Carcinoma
• Intervention / Treatment: Device: Cureety techcare

• Study Type: Interventional
• Enrollment (Estimated): 472
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adeline POITOU; Phone Number: +33658435894; Email: a-poitou@unicancer.fr
• Study Contact Backup: Name: Jérôme LEMONNIER, PhD; Email: j-lemonnier@unicancer.fr

Study Locations

• France
  • Arras, France
    • Not yet recruiting
    • Institut de Cancérologie des Hauts-de-France (ICHF)
  • Auxerre, France
    • Not yet recruiting
    • Centre Hospitalier d'Auxerre
  • Avignon, France
    • Recruiting
    • Sainte Catherine - Institut du Cancer Avignon Provence
  • Bayeux, France
    • Not yet recruiting
    • CH Aunay-Bayeux
  • Beauvais, France
    • Recruiting
    • Centre Hospitalier Simone Veil de Beauvais
  • Beuvry, France
    • Not yet recruiting
    • ICHF - Centre Pierre Curie
  • Blois, France
    • Not yet recruiting
    • Hôpital Simone veil de Blois
  • Bordeaux, France
    • Recruiting
    • Polyclinique Bordeaux Nord
  • Bourg-en-Bresse, France
    • Not yet recruiting
    • Centre Hospitalier Fleyriat
  • Caen, France
    • Not yet recruiting
    • Centre Francois Baclesse
  • Caen, France
    • Not yet recruiting
    • Centre de Cancérologie Privé de Caen Maurice Tubiana
  • Carcassonne, France
    • Recruiting
    • Centre hospitalier de Carcasonne
  • Chambray-lès-Tours, France
    • Not yet recruiting
    • Recherche Oncologie Clinqiue 37 (ROC 37)
  • Cholet, France
    • Recruiting
    • CH de Cholet
  • Colmar, France
    • Not yet recruiting
    • CH Colmar
  • Creil, France
    • Not yet recruiting
    • Groupe Hospitalier public du Sud de l'Oise (GHPSO)
  • Dijon, France
    • Not yet recruiting
    • Centre Georges François Leclerc
  • Dunkirk, France
    • Not yet recruiting
    • Institut Andrée Dutreix
  • Fréjus, France
    • Not yet recruiting
    • Centre Hospitalier Intercommunal de Fréjus Saint Raphael
  • Grenoble, France
    • Not yet recruiting
    • Groupe hospitalier mutualiste de Grenoble
  • La Rochelle, France
    • Not yet recruiting
    • Groupe Hospitalier de La Rochelle-Ré-Aunis
  • La Réunion, France
    • Not yet recruiting
    • CHU de la réunion
  • La Réunion, France
    • Not yet recruiting
    • Clinique sainte Clotilde
  • La Tronche, France
    • Not yet recruiting
    • Chu Grenoble Alpes
  • Le Coudray, France
    • Not yet recruiting
    • Centre Hospitalier Louis Pasteur
  • Le Mans, France
    • Not yet recruiting
    • Centre Hospitalier Le Mans
  • Le Puy-en-Velay, France
    • Not yet recruiting
    • Centre Hospitalier Emile Roux
  • Lorient, France
    • Not yet recruiting
    • GHBS Lorient
  • Lyon, France
    • Not yet recruiting
    • Centre Leon Berard
  • Lyon, France
    • Not yet recruiting
    • Hopital Prive Jean Mermoz
  • Lyon, France
    • Not yet recruiting
    • Clinique de la Sauvegarde
  • Marseille, France
    • Not yet recruiting
    • Institut Paoli Calmettes
  • Mont-de-Marsan, France
    • Not yet recruiting
    • CHI de Mont-de-Marsan et du Pays des Sources
  • Montpellier, France
    • Not yet recruiting
    • Centre de Cancerologie du Grand Montpellier
  • Nantes, France
    • Not yet recruiting
    • Hôpital Privé du Confluent
  • Neuilly-sur-Seine, France
    • Not yet recruiting
    • Clinique Ambroise-Pare Hartmann
  • Neuilly-sur-Seine, France
    • Not yet recruiting
    • Hôpital Américain de Paris
  • Nîmes, France
    • Not yet recruiting
    • CHU de Nîmes
  • Orléans, France
    • Not yet recruiting
    • CHR Orléans
  • Osny, France
    • Not yet recruiting
    • CHP Sainte-Marie
  • Paris, France
    • Not yet recruiting
    • Diaconesses Croix Saint-Simon Hospital Complex
  • Pau, France
    • Recruiting
    • Centre Hospitalier De Pau
  • Plérin, France
    • Not yet recruiting
    • CARIO - Hopital Privé des Cotes d'Armor
  • Poitiers, France
    • Not yet recruiting
    • Chu de Poitiers
  • Reims, France
    • Not yet recruiting
    • Institut Godinot
  • Rouen, France
    • Not yet recruiting
    • Clinique Mathilde - Les Hôpitaux Privés Rouennais
  • Saint-Etienne, France
    • Not yet recruiting
    • CHU de Saint-Etienne
  • Saint-Mandé, France
    • Not yet recruiting
    • Hia Begin
  • Tours, France
    • Not yet recruiting
    • CHU de Tours
  • Vandœuvre-lès-Nancy, France
    • Not yet recruiting
    • Institut de Cancerologie de Lorraine
  • Épagny, France
    • Not yet recruiting
    • Ch Annecy Genevois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard-of-care group
Experimental: Telemonitoring group; Standard of care with digital telemonitoring "Cureety TechCare". The telemonitoring will comprise weekly adverse event (AE) evaluations and their analyses by the "Cureety TechCare".	Device: Cureety techcare; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-treatment failure	Time-to-treatment failure is the time interval (in months) between the initiation of first-line chemotherapy and its premature discontinuation, irrespective of the reason for discontinuation.	From randomization to treatment discontinuation, up to 24 months
Toxicity-free survival	The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the oncology research community as the leading rating scale for adverse events. This scale, divided into five grades (1 = "mild," 2 = "moderate," 3 = "severe," 4 = "life-threatening," and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders. Toxicity-free survival is defined as the time from randomization to the first event among a grade 3-4 non-hematological adverse event (graded using CTCAE version 5.0), a hospitalization for safety reasons, or death from any cause, whichever occurs first.	From randomization until the first event, up to 24 months
Time to clinical deterioration	-Time to clinical deterioration is defined by the time between randomization and deterioration of patient's level of functioning determined by the Eastern Cooperative Oncology Group (ECOG) performance status scale. The ECOG, widely accepted in the community of oncology research to assess how the disease affects the daily living abilities of the patient, is composed of 5 levels from grade 0 (fully active, able to carry on all pre-disease performance without restriction) to grade 5 (dead).	From randomization, to the date of the first clinical deterioration, up to 24 months
Number of treatment lines	Number of successive treatment lines offered to the patient from randomization to the end of the study.	Throughout study completion, up to 24 months
Incidence of Adverse Events	The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.	Throughout study completion, up to 24 months
Quality of life questionnaire - Core 30 (QLQ-C30)	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	At baseline then every 3 weeks, up to 24 months
Quality of Life Questionnaire - Breast cancer module (QLQ-BR45)	This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms or problems for all items.	At baseline then every 3 weeks, up to 24 months
Treatment compliance and extent of exposure	The treatment compliance and extent of exposure will be assess using dose intensity, treatment delays and dose reductions.	Throughout study completion, up to 24 months
Compliance with the use of Cureety digital telemonitoring	Compliance is measured by the frequency of patient responses to the Cureety telemonitoring questionnaires.	Throughout study completion, up to 24 months
Satisfaction with Cureety telemonitoring	Satisfaction with Cureety telemonitoring is measured by the percentage of participants (patients and medical team [including nurse, clinical research associate, and investigators]) satisfied by the regular usage of the Cureety telemonitoring tool.	3 months after randomisation for the patients and 1 year after the site activation for medical team
Patient's global satisfaction with care using the data of the EORTC OUT-PATSAT-35	The OUT-PATSAT35 is a 35-item satisfaction with care questionnaire measuring cancer outpatients' perception of hospital doctors and nurses, as well as aspects of care organisation and services. Each item is rated from 1 to 5 (bad to excellent).	6 months after randomisation
Socio-economic impact of digital telemonitoring	Socio-economic impact of digital telemonitoring will be assessed using the number of days of hospitalization and the number of unscheduled hospitalizations and emergency consultations	Throughout study completion, up to 24 months after randomization

Collaborators and Investigators

• Sponsor: UNICANCER
• Collaborators: Cureety
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 2, 2028

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Telemonitoring; Triple Negative Breast Cancer; Adverse events; Cureety
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms
• Other Study ID Numbers: UC-BCG-2309; IDRCB NUMBER: 2023-A02477-38 (Other Identifier: CPP Sud-Méditerranée III)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No