Clinical trial Recruiting at 1 site Interventional Ages 75 and up Women only

Stereotactic radiotherapy for early breast cancer in elderly women

Official title: Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone

Run by University of Rome Tor Vergata · NCT05071105 · Data updated 2026-11-12

This study is testing a non-surgical radiation treatment for women aged 75 and older with early breast cancer to see if it can effectively target their tumors.

More Breast Cancer Female trials

Quick facts

Study typeInterventional
Ages75 Years and up
SexWomen only
Enrollment30 (estimated)
SponsorUniversity of Rome Tor Vergata
Academic / other
Drugs / interventionschemotherapy, Radiation
Locations1 site (Rome, Rome)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedNovember 11, 2023
Study endsDecember 31, 2026
Registry record updatedMay 30, 2025
Trial IDNCT05071105 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women aged 75 and older with early-stage, hormone-sensitive breast cancer who are not suitable for surgical treatment.

Probably not a fit

Patients with metastatic disease, loco-regional nodal involvement, or multifocal tumors will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of Stereotactic Body Radiation Therapy (SBRT) as a non-invasive treatment option for elderly women aged 75 and older with early-stage breast cancer who are not candidates for surgery. The study aims to provide an effective local treatment alternative for patients who typically receive only hormonal therapy due to age-related comorbidities. By focusing high-intensity radiation on the tumor, the trial seeks to control the primary tumor without the need for surgical intervention. The eligibility criteria include women with specific tumor characteristics and a confirmed diagnosis of local disease only.

Why it matters

Potential benefit: If successful, this approach could provide a viable treatment option for elderly women with early breast cancer, improving their outcomes and quality of life.

How similar studies have gone: While there is limited clinical data on the use of SBRT specifically for breast cancer, similar non-surgical approaches have shown promise in other contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 75 years
* Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0)
* Luminal like A or B (estrogen receptor positive and/or progesterone receptor positive and Her2 negative Tumors)
* SBRT within 2 months after hormonal therapy start

Exclusion Criteria:

* Metastatic Disease
* Evidence of loco-regional nodal disease
* Multifocal or multicentric tumors
* Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields
* Concurrent systemic disorders that contraindicate radiotherapy

Where it's running

  • Fondazione Policlinico Tor Vergata
    Rome, Rome, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.