SBRT in Early Breast Cancer in Elderly Women

Launched by UNIVERSITY OF ROME TOR VERGATA · Sep 27, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called Stereotactic Body Radiation Therapy (SBRT) for elderly women with early-stage breast cancer who are not suitable for surgery due to age or other health issues. The goal is to see if SBRT can effectively control the cancer locally in women aged 75 and older who have hormone-sensitive tumors. Currently, many older women are only receiving hormonal therapy, but this trial aims to explore a possible local treatment option for those who cannot undergo surgery.

To be eligible for the trial, participants need to be at least 75 years old, diagnosed with localized breast cancer (not spread to other areas), and have hormone-sensitive tumors. They will receive SBRT within two months after starting hormonal therapy. Throughout the trial, participants will receive focused radiation treatment in just a few sessions, which is less invasive than traditional surgery. It’s important to note that women with more advanced disease, such as those with metastases or certain other health conditions, will not be included in this study.

Gender

FEMALE

Eligibility 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