Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Stereotactic Body Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione Policlinico Tor Vergata
RECRUITING
Rome
Contact Information
Primary
Laura Cedrone
radioterapia@ptvonline.it
+393669879224
Backup
Cecilia Sciommari
radioterapia@ptvonline.it
+390620908372
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: 40Gy/5fx
The starting dose level will be 8Gy x 5 fractions, i.e., 40 Gy/5 nonconsecutive once-daily fractions.
Experimental: 42.5Gy/5fx
The intermediate dose level will be 8.5Gy x 5 fractions, i.e. 42.5Gy/5 nonconsecutive once-daily fractions.
Experimental: 45Gy/5fx
The higher dose level will be 9Gy x 5 fractions, i.e. 45Gy/5 nonconsecutive once-daily fractions
Sponsors
Leads: University of Rome Tor Vergata

This content was sourced from clinicaltrials.gov