drugset / Trial / NCT04134598
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Phase 3
Active not recruiting
926 enrolled
Careggi University Hospital
University of Florence · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
Rationale and relevance for patients and the scientific community. In low risk early stage patients ≥70 years, exclusive radiation therapy (RT) approach might be superior in terms of Health-Related Quality of Life (HRQoL), when compared to exclusive endocrine therapy (ET) following breast-conserving surgery (BCS). Assuming an equal rate of disease control, unnecessary long-term toxicity of ET may be avoided.
Timeline
- Start
- 2021-02-08
- Primary completion
- 2030-03-31
- Completion
- 2030-03-31
Publications
- Results Meattini I, Poortmans PMP, Marrazzo L, Desideri I, Brain E, Hamaker M, Lambertini M, Miccinesi G, Russell N, Saieva C, Strnad V, Visani L, Kaidar-Person O, Livi L. Exclusive endocrine therapy or partial breast irradiation for women aged >/=70 years with luminal A-like early stage breast cancer (NCT04134598 - EUROPA): Proof of concept of a randomized controlled trial comparing health related quality of life by patient reported outcome measures. J Geriatr Oncol. 2021 Mar;12(2):182-189. doi: 10.1016/j.jgo.2020.07.013. Epub 2020 Jul 29.
- Results Meattini I, De Santis MC, Visani L, Scorsetti M, Fozza A, Meduri B, De Rose F, Bonzano E, Prisco A, Masiello V, La Rocca E, Spoto R, Becherini C, Blandino G, Moscetti L, Colciago RR, Audisio RA, Brain E, Caini S, Hamaker M, Kaidar-Person O, Lambertini M, Marrazzo L, Saieva C, Spanic T, Strnad V, Wheelwright S, Poortmans PMP, Livi L; EUROPA Trial Investigators. Single-modality endocrine therapy versus radiotherapy after breast-conserving surgery in women aged 70 years and older with luminal A-like early breast cancer (EUROPA): a preplanned interim analysis of a phase 3, non-inferiority, randomised trial. Lancet Oncol. 2025 Jan;26(1):37-50. doi: 10.1016/S1470-2045(24)00661-2. Epub 2024 Dec 12.
- Ho AY, Bellon JR. Overcoming Resistance - Omission of Radiotherapy for Low-Risk Breast Cancer. N Engl J Med. 2023 Feb 16;388(7):652-653. doi: 10.1056/NEJMe2216133. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | — | Oral |
| Comparator | Exemestane | Small molecule | — | Oral |
| Comparator | Letrozole | Other / unclassified | — | Oral |
| Comparator | Tamoxifen | Small molecule | — | Oral |