HOPE: Phase III randomized trial of a personalized digital supportive-care pathway (DP) for endocrine therapy (ET) symptoms in early breast cancer (BC)

HOPE ESMO 2026

Paciente / Población Intervención / Exposición Comparación Desenlace

In patients with stage I-III HR+ early breast cancer reporting endocrine therapy symptoms, a personalised digital supportive-care pathway added to standard of care did not significantly improve endocrine therapy symptom burden at 3 months compared with standard of care alone.

N

180pacientes

Diseño

Phase III national hybrid effectiveness-implementation trial in which patients with stage I-III HR+ early breast cancer receiving endocrine therapy and reporting related symptoms were randomised 1:1 to a 3-month personalised digital supportive-care pathway (remote symptom monitoring, needs assessment, tailored education and self-management programmes with low-touch nurse navigation) plus standard of care or standard of care alone (NCT06781996).

Desenlace

EORTC QLQ-BR45 endocrine therapy symptom scale at month 3, analysed by ANCOVA.

ResultadoMean EORTC QLQ-BR45 ET symptom score at M3 34.4 with DP vs 39.8 with SoC alone (baseline 38.7 vs 41.2), adjusted difference -3.4 (SE 2.27; P = 0.136), not statistically significant: the primary endpoint was not met. Other QoL domains were similar. Self-efficacy improved with DP (+1.96; SE 0.91; P = 0.036). Of 180 randomised patients, 162 (90%) completed M3. In the DP arm, 84% used DP as intended, and in an exploratory analysis of intended users the adjusted difference in ET symptom score was -4.2 (SE 2.21; P = 0.056). 87% found DP useful, 89% would recommend it, 16% reported technical issues and 73% received follow-up nurse navigation calls (median 3 per patient).

COCHARD A, Lapidari P, Rivera S, et al. Presented at ESMO Congress 2026, abstract LBA92, 26 October. Not yet published.

Discusión y crítica

HOPE shows that a personalised digital supportive-care pathway was well used and well accepted by a diverse population, but it did not significantly reduce endocrine therapy symptom burden at 3 months. The self-efficacy gain is a secondary finding, and the near-significant result in intended users comes from an exploratory per-use analysis that loses the protection of randomisation. Follow-up was only 3 months, the trial was small with 180 patients, and the abstract does not state blinding, so the patient-reported outcomes may have been open to expectation bias. The abstract gives no adherence, health literacy or wearable-derived results, although these were listed as secondary endpoints, so the effect on endocrine therapy persistence is still unknown.