Actively Recruiting

Phase Not Applicable
Age: 75Years +
FEMALE
NCT05071105

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

Age: 75Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Tor Vergata

Rome, Rome, Italy, 00133

Actively Recruiting

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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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