Phase I/II Clinical Trial on Single Fraction Ablative Preoperative Radiation Treatment for Early Stage Breast Cancer
Who is this study for? Patients with early stage breast cancer
What treatments are being studied? Preoperative ablative radiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically proven unifocal adenocarcinoma
• T1-T2
• Tumor size up to 2.5 cm
• cN0
• Age ≥ 18 years old
• Good general condition (ECOG 0-2)
• Planned BCS
• Written informed consent
Locations
Other Locations
Italy
IEO, European Institute of Oncology IRCCS
RECRUITING
Milan
Contact Information
Primary
Maria Cristina Leonardi, MD
cristina.leonardi@ieo.it
+39 02 57489037
Backup
Anna Morra, MD
anna.morra@ieo.it
+39 02 57489037
Time Frame
Start Date: 2021-07-31
Estimated Completion Date: 2029-03
Participants
Target number of participants: 79
Treatments
Experimental: Preoperative Radiation Treatment
Preoperative Radiation treatment with CyberKnife
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology