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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 75 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Rome, Rome) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | November 11, 2023 |
| Study ends | December 31, 2026 |
| Registry record updated | May 30, 2025 |
| Trial ID | NCT05071105 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
- Principal investigator: Rolando Maria D'Angelillo — Fondazione Policlinico Tor Vergata
- Study coordinator: Laura Cedrone
- Email: radioterapia@ptvonline.it
- Phone: +393669879224
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.