Status:
RECRUITING
Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Cureety
Conditions:
Metastatic Triple-Negative Breast Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 2 2028
Estimated Enrollment :
472 Patients enrolled
Trial Details
Trial ID
NCT06505018
Start Date
July 25 2024
End Date
September 2 2028
Last Update
September 2 2025
Active Locations (51)
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1
Institut de Cancérologie des Hauts-de-France (ICHF)
Arras, France
2
Centre Hospitalier d'Auxerre
Auxerre, France
3
Sainte Catherine - Institut du Cancer Avignon Provence
Avignon, France
4
CH Aunay-Bayeux
Bayeux, France