NCT03520894

Radiotherapy in Preoperative Setting With CyberKnife for Breast Cancer

Radiotherapy in Preoperative Setting With CyberKnife as Treatment in Early Breast Cancer: an Explorative Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to prospectively evaluate, in patients affected by early breast cancer, safety and feasibility of single fraction radiotherapy with Cyberknife R in preoperative setting, and to identify factors predictive for outcome based on biologic and clinical parameters.

Detailed description

Monocentric, open-label, single-arm phase II study evaluating safety and efficacy of neoadjuvant radiotherapy in early breast cancer patients. Patients eligible are women aged 50 or more years old, affected by histologically proven invasive breast cancer, with positive hormonal receptors, grading 1 or 2, HER-2 negative, without lymphovascular invasion, and tumour size up to 2 cm (measured on mammography, ultrasound or magnetic resonance), negative clinical nodal status, eligible for BCS.

Conditions

• Early Breast Cancer

Interventions

Type	Name	Description
RADIATION	Neoadjuvant radiotherapy	single 21 Gy fraction of Radiotherapy before surgery

Timeline

• Start date: 2018-05-01
• Primary completion: 2022-05-01
• Completion: 2024-05-01
• First posted: 2018-05-11
• Last updated: 2019-10-22

Locations

1 site across 1 country: Italy