A Phase 3 clinical trial investigating a digital self-management support tool for patients with Breast Cancer reached its primary completion on 2026-03-15. The study enrolled 180 participants.
Background
Breast cancer is a common malignancy, and for many patients, adjuvant hormonal therapy is a crucial part of treatment to reduce recurrence risk. While effective, this therapy can lead to various adverse events that significantly impact a patient's quality of life. Managing these side effects is essential for treatment adherence and overall well-being. Digital self-management tools offer a potential avenue to provide personalized support and education, helping patients better cope with treatment-related challenges and improve their daily lives during this critical treatment phase.
Trial design
This Phase 3 trial, NCT06781996, enrolled 180 participants with Breast Cancer, specifically early-stage breast cancer (Stage 1-3) who were undergoing adjuvant hormonal therapy and reporting endocrine therapy related adverse events. The study is a national, prospective, randomized, open-label trial conducted in France. Participants were randomly assigned 1:1 to either receive a 12-week multimodal Resilience© digital companion, including education and self-care modules, in addition to standard of care, or standard of care alone. The digital companion is a personalized digitally-enabled pathway delivered by a mobile application.
What this means
The primary completion of this Phase 3 trial signifies a significant milestone in the evaluation of a digital self-management tool for early breast cancer patients undergoing adjuvant hormonal therapy. While specific results are not yet available, the completion of data collection for the primary endpoint brings the medical community closer to understanding the efficacy of such digital interventions in improving quality of life and managing treatment-related adverse events. If successful, this digital companion could offer a valuable, accessible resource for patients to enhance their self-care and support during a challenging treatment period.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT06781996, titled "A Study to Determine the Efficacy of a Digital Self-management Support Tool to Improve the Quality of Life During Adjuvant HOrmonal Therapy for Patients With Early Breast Cancer", was posted on 2026-03-15 on clinicaltrials.gov.