Phase Ib Study of Preoperative Single-Dose GammaPod Radiation for Early-Stage Breast Cancer

What this Trial Is About

Researchers are studying early-stage breast cancer treatment by evaluating a new approach using the GammaPod machine, which is FDA approved to deliver focused radiation specifically to the breast. This technology aims to target radiation precisely to the tumor area, reducing exposure to nearby healthy tissues. The study focuses on delivering radiation before surgery, which has shown improved disease-free survival in some cancers, and seeks to find a safe and effective radiation dose while assessing skin changes and quality of life after treatment. Participants will receive one of four different dose levels of preoperative radiation therapy to the partial breast using the GammaPod device. This treatment is given before the lumpectomy surgery, which removes the tumor. The study is a dose-escalation phase Ib trial, with dose levels ranging from 21 Gy to 30 Gy delivered in a single fraction. Each participants breast is held securely in place by a breast cup system during treatment for precise targeting. During the study, participants will be closely monitored for dose-limiting toxicities and safety outcomes over five years. Researchers will assess radiation-related skin changes using questionnaires from patients and physicians and photo software analysis tools. Other evaluations include tumor response, local tumor recurrence, and quality of life measures. The study involves imaging with CT and MRI scans and requires participants to lie prone for treatment. The total follow-up duration is five years to determine the maximum tolerated dose and safety profile of this radiation approach.

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer