Using a telemonitoring platform to support treatment for metastatic triple-negative breast cancer
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
NA · UNICANCER · NCT06505018
This study is testing if a new telemonitoring system can help people with metastatic triple-negative breast cancer feel better and stay out of the hospital while they start their first treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 472 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UNICANCER (other) |
| Locations | 51 sites (Arras and 50 other locations) |
| Trial ID | NCT06505018 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the telemonitoring platform 'CUREETY TECHCARE' in conjunction with standard care for patients with metastatic triple-negative breast cancer who are starting their first-line treatment. The study aims to determine if telemonitoring can improve patient quality of life, reduce hospitalization rates, and enhance overall survival compared to standard care alone. Participants will report their symptoms through the platform, which will analyze their condition and provide feedback to both patients and medical staff. The trial compares outcomes between those using the telemonitoring platform and those receiving only standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic triple-negative breast cancer who are starting first-line systemic treatment.
Not a fit: Patients who are not initiating treatment or have a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life and better health outcomes for patients with metastatic triple-negative breast cancer.
How similar studies have performed: Other studies have shown promising results with telemonitoring in cancer care, suggesting potential benefits in patient management and outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Arras and 50 other locations
- Institut de Cancérologie des Hauts-de-France (ICHF) — Arras, France (NOT_YET_RECRUITING)
- Centre Hospitalier d'Auxerre — Auxerre, France (NOT_YET_RECRUITING)
- Sainte Catherine - Institut du Cancer Avignon Provence — Avignon, France (RECRUITING)
- CH Aunay-Bayeux — Bayeux, France (NOT_YET_RECRUITING)
- Centre Hospitalier Simone Veil de Beauvais — Beauvais, France (RECRUITING)
- ICHF - Centre Pierre Curie — Beuvry, France (NOT_YET_RECRUITING)
- Hôpital Simone Veil de Blois — Blois, France (NOT_YET_RECRUITING)
- Polyclinique bordeaux nord — Bordeaux, France (RECRUITING)
- Centre Hospitalier Fleyriat — Bourg-en-Bresse, France (NOT_YET_RECRUITING)
- Centre de Cancérologie Privé de Caen Maurice Tubiana — Caen, France (NOT_YET_RECRUITING)
- Centre Francois Baclesse — Caen, France (NOT_YET_RECRUITING)
- Centre hospitalier de Carcasonne — Carcassonne, France (RECRUITING)
- Recherche Oncologie Clinqiue 37 (ROC 37) — Chambray-lès-Tours, France (NOT_YET_RECRUITING)
- CH de Cholet — Cholet, France (RECRUITING)
- CH Colmar — Colmar, France (NOT_YET_RECRUITING)
- Groupe Hospitalier Public du Sud de l'Oise (GHPSO) — Creil, France (NOT_YET_RECRUITING)
- Centre Georges François Leclerc — Dijon, France (NOT_YET_RECRUITING)
- Institut Andrée Dutreix — Dunkirk, France (NOT_YET_RECRUITING)
- CH Annecy Genevois — Épagny, France (NOT_YET_RECRUITING)
- Centre Hospitalier Intercommunal de Fréjus Saint Raphael — Fréjus, France (NOT_YET_RECRUITING)
- Groupe Hospitalier Mutualiste de Grenoble — Grenoble, France (NOT_YET_RECRUITING)
- CHU de la réunion — La Réunion, France (NOT_YET_RECRUITING)
- Clinique Sainte Clotilde — La Réunion, France (NOT_YET_RECRUITING)
- Groupe Hospitalier de La Rochelle-Ré-Aunis — La Rochelle, France (NOT_YET_RECRUITING)
- CHU Grenoble Alpes — La Tronche, France (NOT_YET_RECRUITING)
- Centre Hospitalier Louis Pasteur — Le Coudray, France (NOT_YET_RECRUITING)
- Centre Hospitalier Le Mans — Le Mans, France (NOT_YET_RECRUITING)
- Centre Hospitalier Emile Roux — Le Puy-en-Velay, France (NOT_YET_RECRUITING)
- GHBS Lorient — Lorient, France (NOT_YET_RECRUITING)
- Centre Leon Berard — Lyon, France (NOT_YET_RECRUITING)
- Clinique de la Sauvegarde — Lyon, France (NOT_YET_RECRUITING)
- Hôpital Privé Jean Mermoz — Lyon, France (NOT_YET_RECRUITING)
- Institut Paoli Calmettes — Marseille, France (NOT_YET_RECRUITING)
- CHI de Mont-de-Marsan et du Pays des Sources — Mont-de-Marsan, France (NOT_YET_RECRUITING)
- Centre de Cancérologie du Grand Montpellier — Montpellier, France (NOT_YET_RECRUITING)
- Hôpital Privé du Confluent — Nantes, France (NOT_YET_RECRUITING)
- Clinique Ambroise-Pare Hartmann — Neuilly-sur-Seine, France (NOT_YET_RECRUITING)
- Hôpital Américain de PARIS — Neuilly-sur-Seine, France (NOT_YET_RECRUITING)
- CHU de Nimes — Nîmes, France (NOT_YET_RECRUITING)
- CHR Orleans — Orléans, France (NOT_YET_RECRUITING)
- CHP Sainte-Marie — Osny, France (NOT_YET_RECRUITING)
- Diaconesses Croix Saint-Simon Hospital Complex — Paris, France (NOT_YET_RECRUITING)
- Centre hospitalier de Pau — Pau, France (RECRUITING)
- CARIO - Hopital Privé des Cotes d'Armor — Plérin, France (NOT_YET_RECRUITING)
- CHU de Poitiers — Poitiers, France (NOT_YET_RECRUITING)
- Institut Godinot — Reims, France (NOT_YET_RECRUITING)
- Clinique Mathilde - Les Hôpitaux Privés Rouennais — Rouen, France (NOT_YET_RECRUITING)
- CHU de Saint-Etienne — Saint-Etienne, France (NOT_YET_RECRUITING)
- Hia Begin — Saint-Mandé, France (NOT_YET_RECRUITING)
- CHU de Tours — Tours, France (NOT_YET_RECRUITING)
+1 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Jérôme MARTIN-BABAU, MD — Armorican Centre for Radiotherapy, Medical Imaging and Oncology, CARIO, Plérin
- Study coordinator: Adeline POITOU
- Email: a-poitou@unicancer.fr
- Phone: +33658435894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Triple-Negative Breast Carcinoma, Telemonitoring, Triple Negative Breast Cancer, Cureety, Adverse events