Actively Recruiting
SBRT in Early Breast Cancer in Elderly Women
Led by University of Rome Tor Vergata · Updated on 2025-05-30
30
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy. In Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor. In recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery. Stereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting. Against this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.
CONDITIONS
Official Title
SBRT in Early Breast Cancer in Elderly Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 75 years or older
- Histologically confirmed local breast cancer (cT1-T2 N0 M0)
- Luminal like A or B tumor (estrogen and/or progesterone receptor positive and Her2 negative)
- SBRT planned within 2 months after starting hormone therapy
You will not qualify if you...
- Presence of metastatic disease
- Evidence of cancer spread to regional lymph nodes
- Multifocal or multicentric breast tumors
- Previous radiotherapy overlapping with the study area
- Other systemic health conditions that prevent radiotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Tor Vergata
Rome, Rome, Italy, 00133
Actively Recruiting
Research Team
L
Laura Cedrone
CONTACT
C
Cecilia Sciommari
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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