MedTrace Logo

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

NCT04134598 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 926

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Breast irradiation (RT)

Irradiation of volume's portion Index quadrant) or whole volume of the residual breast.

DRUG

Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen

Adjuvant endocrine therapy as per local policy (letrozole/anastrozole/exemestane/tamoxifene for 5-year or switch schedules aromatase inhibitors/tamoxifen for 5-year).

Sponsors & Collaborators

  • University of Florence

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Lorenzo Livi, MD,Prof · University of Florence, Florence, Italy

  • Philip M Poortmans, MD,PhD,Prof · Iridium Kankernetwerk - University of Antwerp; Wilrijk-Antwerp, Belgium

  • Icro Meattini, MD,Prof · University of Florence, Florence, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2030-03-31
Completion
2030-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04134598 on ClinicalTrials.gov