NCT04134598: EUROPA

ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer

Active, enrolled Phase 3 Last updated 29 August 2025

What this trial tests

Phase 3 trial testing Breast irradiation (RT) in Breast Cancer in 926 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 February 2021

Primary endpoint
31 March 2030

31 March 2030

Quick facts

Lead sponsor	Azienda Ospedaliero-Universitaria Careggi
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	926
Start date	8 February 2021
Primary completion	31 March 2030
Estimated completion	31 March 2030
Sites	1 location across Italy

Drugs / interventions tested

• Breast irradiation (RT)
• Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Azienda Ospedaliero-Universitaria Careggi — full company profile →

Who can join

70 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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 measure
   Meattini I, Poortmans PMP, Marrazzo L, Desideri I, et al · · 2021 · cited 49× · PMID 32739355 · DOI 10.1016/j.jgo.2020.07.013
2. 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.
   Meattini I, De Santis MC, Visani L, Scorsetti M, et al · · 2025 · cited 41× · PMID 39675376 · DOI 10.1016/s1470-2045(24)00661-2
3. Omission of postoperative radiation after breast conserving surgery: A progressive paradigm shift towards precision medicine.
   Franco P, De Rose F, De Santis MC, Pasinetti N, et al · · 2020 · cited 27× · PMID 32090175 · DOI 10.1016/j.ctro.2020.02.003
4. Molecular Insights on Signaling Cascades in Breast Cancer: A Comprehensive Review.
   Panda VK, Mishra B, Mahapatra S, Swain B, et al · · 2025 · cited 17× · PMID 39858015 · DOI 10.3390/cancers17020234
5. Optimal adjuvant therapy in older (≥70 years of age) women with low-risk early-stage breast cancer.
   Chadha M, White J, Swain SM, Rakovitch E, et al · · 2023 · cited 11× · PMID 38097623 · DOI 10.1038/s41523-023-00591-6
6. <b>E</b>ndocrine therapy with accelerated <b>P</b>artial breast irradiati<b>O</b>n or exclusive ultra-accelerated <b>P</b>artial breast irradiation for women aged ≥ 60 years with <b>E</b>arly-stage breast cancer (EPOPE): The rationale for a GEC-ESTRO randomized phase III-controll
   Hannoun-Levi JM, Chamorey E, Boulahssass R, Polgar C, et al · · 2021 · cited 11× · PMID 33997321 · DOI 10.1016/j.ctro.2021.04.005
7. Intraoperative radiotherapy for early breast cancer - insufficient evidence to change practice.
   Sasieni PD, Sawyer EJ. · · 2020 · cited 10× · PMID 33087894 · DOI 10.1038/s41571-020-00444-2
8. What do patients and health care professionals view as important attributes in radiotherapy decisions? Input for a breast cancer patient decision aid.
   Raphael DB, Ter Stege JA, Russell NS, Boersma LJ, et al · · 2020 · cited 10× · PMID 31812074 · DOI 10.1016/j.breast.2019.11.005