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OncoMatch/Clinical Trials/NCT06781996

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

Is NCT06781996 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies non-drug interventions for breast cancer.

Phase 3RecruitingGustave Roussy, Cancer Campus, Grand ParisNCT06781996Data as of May 2026

Randomized trial that compares a personalized digitally-enabled pathway delivered by a mobile application in addition to standard of care vs. standard of care alone in patients with HR+ early breast cancer reporting endocrine therapy related adverse events. The HOPE study is a national, prospective, randomized, open-label trial conducted in France. 180 patients will be randomly assigned 1:1 to receive either 12 weeks of multimodal Resilience© digital companion including education and self-care modules in addition to the standard of care provided by their treating oncologists and supportive care team at their care centers or 12 weeks of standard of care provided by their treating oncologists and supportive care team at their care centers. Data from the literature in oncology trials with Patient-Reported Outcomes suggests that in the absence of double-blind concealment, clinically important differences could still be detected.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 overexpression

histologically confirmed ER and/or PgR positive HR+ invasive BC

Required: PR (PGR) overexpression

histologically confirmed ER and/or PgR positive HR+ invasive BC

Disease stage

Required: Stage I, II, III

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: endocrine therapy (tamoxifen, aromatase inhibitor) — adjuvant

Patients must be actively on ET for their breast cancer diagnosis (any type, including either tamoxifen or an aromatase-inhibitor with or without targeted agents) at the time of study enrollment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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