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Compares treatment options for Metastatic Triple-Negative Breast Carcinoma
Official title Telemonitoring Platform "CUREETY TECHCARE" vs Standard of Care for mTBNC Patients Initiating a First-line Treatment
ClinicalTrials.gov ID: NCT06505018
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed a written informed consent form prior to participate in the study. Note: In case of physical incapacitation, a trusted representative of their...
- Patients ≥18 years of age.
- Patient with histologically documented metastatic triple negative breast cancer (ER (Oestrogen receptor) and PR (Progesterone receptor) \<10%, Her2...
- Life expectancy \> 6 months as per investigator estimate.
- Patient initiating a marketed authorized first-line systemic treatment in the metastatic setting.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Arras, France
- Auxerre, France
- Avignon, France
- Bayeux, France
- Beauvais, France
- Beuvry, France
- Blois, France
- Bordeaux, France
- Bourg-en-Bresse, France
- Caen, France
- Carcassonne, France
- Chambray-lès-Tours, France
- Cholet, France
- Colmar, France
- Creil, France
- Dijon, France
- Dunkirk, France
- Épagny, France
- Fréjus, France
- Grenoble, France
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arras, France; Auxerre, France; Avignon, France; Bayeux, France; Beauvais, France; Beuvry, France and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.