NCT06505018Terminated
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Reason given: The study was terminated prematurely due to insufficient patient recruitment.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 10 Jul 2024
- Start date
- 25 Jul 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- UNICANCER
- NCT number
- NCT06505018
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie des Hauts-de-France (ICHF) | Arras | France | Unknown status |
| Centre Hospitalier d'Auxerre | Auxerre | France | Unknown status |
| Sainte Catherine Institut du Cancer Avignon Provence | Avignon | France | Unknown status |
| Ch Aunay-Bayeux | Bayeux | France | Unknown status |
| Centre Hospitalier Simone Veil De Beauvais | Beauvais | France | Unknown status |
| ICHF Centre Pierre Curie | Beuvry | France | Unknown status |
| Hôpital Simone Veil de Blois | Blois | France | Unknown status |
| Polyclinique Bordeaux Nord | Bordeaux | France | Unknown status |
| Centre hospitalier Fleyriat | Bourg-en-Bresse | France | Unknown status |
| Centre François Baclesse | Caen | France | Unknown status |
| Centre de Cancérologie Privé de Caen Maurice Tubiana | Caen | France | Unknown status |
| Centre hospitalier de Carcasonne | Carcassonne | France | Unknown status |
| Recherche Oncologie Clinqiue 37 (ROC 37) | Chambray-lès-Tours | France | Unknown status |
| Ch de Cholet | Cholet | France | Unknown status |
| CH Colmar | Colmar | France | Unknown status |
| Groupe Hospitalier Public du Sud de l'Oise (GHPSO) | Creil | France | Unknown status |
| Centre Georges François Leclerc | Dijon | France | Unknown status |
| Institut Andree Dutreix | Dunkirk | France | Unknown status |
| CH Annecy Genevois | Épagny | France | Unknown status |
| Centre Hospitalier Intercommunal de Fréjus Saint Raphael | Fréjus | France | Unknown status |
| Groupe Hospitalier Mutualiste de Grenoble | Grenoble | France | Unknown status |
| Clinique Sainte Clotilde | La Réunion | France | Unknown status |
| CHU de la Réunion | La Réunion | France | Unknown status |
| Groupe Hospitalier de la Rochelle Re-Aunis | La Rochelle | France | Unknown status |
| Chu Grenoble Alpes | La Tronche | France | Unknown status |
| Centre Hospitalier Louis Pasteur | Le Coudray | France | Unknown status |
| Centre Hospitalier Le Mans | Le Mans | France | Unknown status |
| Centre Hospitalier Emile Roux | Le Puy-en-Velay | France | Unknown status |
| GHBS Lorient | LORIENT | France | Unknown status |
| Hôpital Privé Jean Mermoz | Lyon | France | Unknown status |
| Clinique de La Sauvegarde | Lyon | France | Unknown status |
| Centre Leon Berard | Lyon | France | Unknown status |
| Institut Paoli-Calmettes | Marseille | France | Unknown status |
| CHI de Mont-de-Marsan et du Pays des Sources | Mont-de-Marsan | France | Unknown status |
| Centre de Cancérologie du Grand Montpellier | Montpellier | France | Unknown status |
| Hôpital Privé du Confluent | Nantes | France | Unknown status |
| Clinique Ambroise-Pare Hartmann | Neuilly-sur-Seine | France | Unknown status |
| Hôpital Américain de Paris | Neuilly-sur-Seine | France | Unknown status |
| CHU de Nîmes | Nîmes | France | Unknown status |
| CHR Orléans | Orléans | France | Unknown status |
| CHP Sainte-Marie | Osny | France | Unknown status |
| Diaconesses Croix Saint-Simon Hospital Complex | Paris | France | Unknown status |
| Centre Hospitalier de Pau | Pau | France | Unknown status |
| CARIO Hôpital Privé des Côtes d'Armor | Plérin | France | Unknown status |
| CHU de Poitiers | Poitiers | France | Unknown status |
| Institut Godinot | Reims | France | Unknown status |
| Clinique Mathilde - Les Hôpitaux Privés Rouennais | Rouen | France | Unknown status |
| Chu de Saint Etienne | Saint-Etienne | France | Unknown status |
| HIA Begin | Saint-Mandé | France | Unknown status |
| CHU de Tours | Tours | France | Unknown status |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.