Stereotactic radiotherapy for early breast cancer in elderly women
Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 75 Years and up |
| Sex | Female |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT05071105 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with metastatic disease, loco-regional nodal involvement, or multifocal tumors will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, Rome
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.