SBRT in Early Breast Cancer in Elderly Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age75+
SponsorUniversity of Rome Tor Vergata

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy

Treatment groups

30 Participants
are divided into 3 treatment groups

Sponsors and collaborators