Metastatic Triple-Negative Breast CarcinomaALTERNATIVENCT06505018
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
A study testing Cureety techcare in people with Metastatic Triple-Negative Breast Carcinoma, run by UNICANCER at 51 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Triple-Negative Breast Carcinoma
- What is being tested?
- Cureety techcare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 51 sitesFrance
- Study dates
- 25 Jul 2024to 12 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
France51 sites
Institut de Cancérologie des Hauts-de-France (ICHF)
Arras
Centre Hospitalier d'Auxerre
Auxerre
Sainte Catherine - Institut du Cancer Avignon Provence
Avignon
CH Aunay-Bayeux
Bayeux
Centre Hospitalier Simone Veil de Beauvais
Beauvais
ICHF - Centre Pierre Curie
Beuvry
Hôpital Simone Veil de Blois
Blois
Polyclinique bordeaux nord
Bordeaux
Centre Hospitalier Fleyriat
Bourg-en-Bresse
Centre de Cancérologie Privé de Caen Maurice Tubiana
Caen
Centre Francois Baclesse
Caen
Centre hospitalier de Carcasonne
Carcassonne
Recherche Oncologie Clinqiue 37 (ROC 37)
Chambray-lès-Tours
CH de Cholet
Cholet
CH Colmar
Colmar
Groupe Hospitalier Public du Sud de l'Oise (GHPSO)
Creil
Centre Georges François Leclerc
Dijon
Institut Andrée Dutreix
Dunkirk
CH Annecy Genevois
Épagny
Centre Hospitalier Intercommunal de Fréjus Saint Raphael
Fréjus
Groupe Hospitalier Mutualiste de Grenoble
Grenoble
CHU de la réunion
La Réunion
Clinique Sainte Clotilde
La Réunion
Groupe Hospitalier de La Rochelle-Ré-Aunis
La Rochelle
CHU Grenoble Alpes
La Tronche
Centre Hospitalier Louis Pasteur
Le Coudray
Centre Hospitalier Le Mans
Le Mans
Centre Hospitalier Emile Roux
Le Puy-en-Velay
GHBS Lorient
Lorient
Centre Leon Berard
Lyon
Clinique de la Sauvegarde
Lyon
Hôpital Privé Jean Mermoz
Lyon
Institut Paoli Calmettes
Marseille
CHI de Mont-de-Marsan et du Pays des Sources
Mont-de-Marsan
Centre de Cancérologie du Grand Montpellier
Montpellier
Hôpital Privé du Confluent
Nantes
Clinique Ambroise-Pare Hartmann
Neuilly-sur-Seine
Hôpital Américain de PARIS
Neuilly-sur-Seine
CHU de Nimes
Nîmes
CHR Orleans
Orléans
CHP Sainte-Marie
Osny
Diaconesses Croix Saint-Simon Hospital Complex
Paris
Centre hospitalier de Pau
Pau
CARIO - Hopital Privé des Cotes d'Armor
Plérin
CHU de Poitiers
Poitiers
Institut Godinot
Reims
Clinique Mathilde - Les Hôpitaux Privés Rouennais
Rouen
CHU de Saint-Etienne
Saint-Etienne
Hia Begin
Saint-Mandé
CHU de Tours
Tours
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
About this study
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
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:
Read more
- 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.
- Being tested
- Cureety techcare
- Keywords
- Telemonitoring, Triple Negative Breast Cancer, Cureety, Adverse events
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cureety techcareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring group | Experimental | Standard of care with digital telemonitoring "Cureety TechCare". The telemonitoring will comprise weekly adverse event (AE) evaluations and their analyses by the "Cureety TechCare". Receives: Device: Cureety techcare |
| Standard-of-care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From randomization to death from any cause, up to 24 months after last inclusion
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Throughout study completion, up to 24 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start25 Jul 2024
- Primary completion1 Dec 2025
- Study completion12 Dec 2025
Why it stopped: The study was terminated prematurely due to insufficient patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Triple-Negative Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- Cureety
- Responsible party
- Sponsor
- Investigators
- Jérôme MARTIN-BABAU, MD, Principal investigator, Armorican Centre for Radiotherapy, Medical Imaging and Oncology, CARIO, PlérinFlorence JOLY, MD, Principal investigator, François Baclesse Center, CaenFrédéric FITENI, MD, Principal investigator, University hospital of Nîmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505018
- Sponsor's protocol ID
- UC-BCG-2309
- Other IDs
- IDRCB NUMBER: 2023-A02477-38
- Acronym
- ALTERNATIVE
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.