Accelerated Partial Breast Radiotherapy Study of a Personalized Holder for Prone Breast Immobilization to Enhance Local Delivery
The goal of this clinical trial is to find out whether using a personalized breast holder (called VENUS SHELL™) can improve positioning and patient comfort during prone radiotherapy (radiotherapy given while the patient lies on her stomach). The main goals of the study are: * To confirm that using the VENUS SHELL™ is safe and effective * To assess whether the VENUS SHELL™ helps deliver accurate radiation treatment in a faster and more comfortable way Participants will: * Attend a study visit before radiotherapy to have a breast surface scan (no radiation) and enable the production of their personalized VENUS SHELL™ * Use their VENUS SHELL™ during radiotherapy planning and treatment * Be asked to complete questionnaires about their comfort
• Written informed consent according to ICH/GCP regulations before registration and prior to any study-specific procedures
• Upfront breast conservative surgery
• Radiotherapy planned within 12 weeks after surgery
• ECOG/WHO performance status ≤2
• Age ≥40 year
⁃ For invasive breast cancer only:
• Staging pT1-T2, N0M0 (Tumor size ≤3 cm)
• If no sentinel lymph node biopsy performed, patient must be clinically N0
• Negative margins (no tumor on ink)
⁃ For ductal carcinoma in situ only:
• Staging pTis (tumor size ≤3 cm)
• Negative margins (≥2 mm)