Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
Summary
The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.
Arms & interventions
- RadiationStereotactic Ablative Breast Radiotherapy
Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following: * Dose Level I: 35 Gy (5 fractions of 7 Gy) * Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy) * Dose Level III: 45 Gy (5 fractions of 9 Gy) * Dose Level IV: 50 Gy (5 fractions of 10 Gy)
Outcome measures
Primary
Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time frame: Up to 13 Weeks
Secondary
Number of Participants Experiencing Treatment-Related Toxicity
Time frame: Up to 13 weeks
Percentage of participants with Complete Pathological Response (pCR)
Time frame: Up to 9 weeks
Cosmesis Evaluation
Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Participant-Reported Health-Related Quality of Life (HR-QoL)
Time frame: 1, 6 ,12 and 24 months post-therapy, up to 2.5 years
Eligibility criteria
Study locations (1)
University of Miami
Miami, Florida, 33136