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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

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut de Cancérologie des Hauts-de-France (ICHF)ArrasFranceUnknown status
Centre Hospitalier d'AuxerreAuxerreFranceUnknown status
Sainte Catherine Institut du Cancer Avignon ProvenceAvignonFranceUnknown status
Ch Aunay-BayeuxBayeuxFranceUnknown status
Centre Hospitalier Simone Veil De BeauvaisBeauvaisFranceUnknown status
ICHF Centre Pierre CurieBeuvryFranceUnknown status
Hôpital Simone Veil de BloisBloisFranceUnknown status
Polyclinique Bordeaux NordBordeauxFranceUnknown status
Centre hospitalier FleyriatBourg-en-BresseFranceUnknown status
Centre François BaclesseCaenFranceUnknown status
Centre de Cancérologie Privé de Caen Maurice TubianaCaenFranceUnknown status
Centre hospitalier de CarcasonneCarcassonneFranceUnknown status
Recherche Oncologie Clinqiue 37 (ROC 37)Chambray-lès-ToursFranceUnknown status
Ch de CholetCholetFranceUnknown status
CH ColmarColmarFranceUnknown status
Groupe Hospitalier Public du Sud de l'Oise (GHPSO)CreilFranceUnknown status
Centre Georges François LeclercDijonFranceUnknown status
Institut Andree DutreixDunkirkFranceUnknown status
CH Annecy GenevoisÉpagnyFranceUnknown status
Centre Hospitalier Intercommunal de Fréjus Saint RaphaelFréjusFranceUnknown status
Groupe Hospitalier Mutualiste de GrenobleGrenobleFranceUnknown status
Clinique Sainte ClotildeLa RéunionFranceUnknown status
CHU de la RéunionLa RéunionFranceUnknown status
Groupe Hospitalier de la Rochelle Re-AunisLa RochelleFranceUnknown status
Chu Grenoble AlpesLa TroncheFranceUnknown status
Centre Hospitalier Louis PasteurLe CoudrayFranceUnknown status
Centre Hospitalier Le MansLe MansFranceUnknown status
Centre Hospitalier Emile RouxLe Puy-en-VelayFranceUnknown status
GHBS LorientLORIENTFranceUnknown status
Hôpital Privé Jean MermozLyonFranceUnknown status
Clinique de La SauvegardeLyonFranceUnknown status
Centre Leon BerardLyonFranceUnknown status
Institut Paoli-CalmettesMarseilleFranceUnknown status
CHI de Mont-de-Marsan et du Pays des SourcesMont-de-MarsanFranceUnknown status
Centre de Cancérologie du Grand MontpellierMontpellierFranceUnknown status
Hôpital Privé du ConfluentNantesFranceUnknown status
Clinique Ambroise-Pare HartmannNeuilly-sur-SeineFranceUnknown status
Hôpital Américain de ParisNeuilly-sur-SeineFranceUnknown status
CHU de NîmesNîmesFranceUnknown status
CHR OrléansOrléansFranceUnknown status
CHP Sainte-MarieOsnyFranceUnknown status
Diaconesses Croix Saint-Simon Hospital ComplexParisFranceUnknown status
Centre Hospitalier de PauPauFranceUnknown status
CARIO Hôpital Privé des Côtes d'ArmorPlérinFranceUnknown status
CHU de PoitiersPoitiersFranceUnknown status
Institut GodinotReimsFranceUnknown status
Clinique Mathilde - Les Hôpitaux Privés RouennaisRouenFranceUnknown status
Chu de Saint EtienneSaint-EtienneFranceUnknown status
HIA BeginSaint-MandéFranceUnknown status
CHU de ToursToursFranceUnknown status
Institut de Cancérologie de LorraineVandœuvre-lès-NancyFranceUnknown status

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