Actively Recruiting
Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
Led by Shanghai Proton and Heavy Ion Center · Updated on 2025-08-22
312
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast-conserving surgery (BCS) followed by whole-breast irradiation (WBI) remains the standard therapeutic approach for early-stage breast cancer. Long-term follow-up data from the FAST trial (10-year analysis) demonstrated that the 28.5 Gy/5-fraction regimen exhibited comparable adverse effects to the conventional 50 Gy/25-fraction regimen, with no statistically significant differences in photographic cosmetic assessments at 2 and 5 years post-treatment. The FAST-Forward trial demonstrated comparable 5-year ipsilateral breast tumor recurrence rates (IBTR) and incidence of radiation-related toxicities between ultra-hypofractionated whole-breast irradiation (UH-WBI; 26 Gy in 5 fractions over 1 week) and moderately hypofractionated whole-breast irradiation (MH-WBI; 40 Gy in 15 fractions over 3 weeks). Additionally, no statistically significant difference in cosmetic outcomes was observed between the two regimens at the 2-year follow-up. Proton radiotherapy enables precise dose delivery to tumor targets while minimizing radiation exposure to surrounding normal tissues, thereby reducing treatment-related toxicities. However, current clinical protocols predominantly employ conventional fractionation for proton therapy, with a paucity of robust evidence evaluating the efficacy and safety of ultra-hypofractionated proton radiotherapy in breast cancer patients. This prospective randomized controlled trial aims to establish high-level scientific evidence for the clinical application of ultra-hypofractionated proton radiotherapy following BCS, ensuring non-inferiority in oncologic control, toxicity profiles, and cosmetic preservation compared to standard regimens.
CONDITIONS
Official Title
Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Diagnosed with unilateral primary invasive breast cancer confirmed by pathology
- Have had breast-conserving surgery plus sentinel lymph node biopsy or axillary lymph node dissection with negative margins of 2 mm or more
- No distant metastasis as confirmed by CT, MRI, bone scan, and PET/CT
- No prior radiation therapy to the same breast or chest
- ECOG performance status between 0 and 2 or Karnofsky Performance Status of 70 or higher
You will not qualify if you...
- No pathology diagnosis available
- Positive or close surgical margins less than 2 mm
- Presence of lymph node or distant metastasis
- Bilateral breast cancer or history of cancer in the opposite breast
- Prior radiation therapy to the same breast or chest
- Pregnancy or currently breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion Center
Shanghai, China
Actively Recruiting
Research Team
P
Ping Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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