A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

Résumé

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Invasive Breast Cancer-Free Survival (IBCFS)

   Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause

   Délai Up to 5 years

2. Critère de jugement secondaire

   Distant Relapse-Free Survival (DRFS)

   Assessed by the time from date of randomization to the date of first occurrence of: * Distant recurrence, or * Death attributable to any cause

   Délai Up to 5 years

3. Critère de jugement secondaire

   Overall Survival (OS)

   Délai Up to 5 years

4. Critère de jugement secondaire

   Invasive Disease-Free Survival (IDFS)

   Assessed by the time from date of randomization to the date of first occurrence of: * Local/regional recurrence * Contralateral recurrence * Second primary non-breast invasive cancer * Distant recurrence, or * Death attributable to any cause

   Délai Up to 5 years

5. Critère de jugement secondaire

   Number of Participants With Adverse Events (AEs)

   Délai Up to 5 years plus 28 days

6. Critère de jugement secondaire

   Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

   Délai Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

7. Critère de jugement secondaire

   Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30

   Délai Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

8. Critère de jugement secondaire

   Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)

   Délai Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

9. Critère de jugement secondaire

   Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)

   Délai Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5

10. Critère de jugement secondaire

    Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant

    Délai Predose up to 4 hours postdose

11. Critère de jugement secondaire

    Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant

    Délai Predose up to 4 hours postdose

Dates

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

501 sites sont en recrutement

517 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

1. 15 septembre 2026

   Site ajouté

   5 sites added (567 total)

   562 → 567

2. 17 août 2026

   Site ajouté

   7 sites added (562 total)

   555 → 562