Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT06505018
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06505018
Study Brief:
Protocol Section:
NCT06505018