Status:
RECRUITING
Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
Lead Sponsor:
Shanghai Proton and Heavy Ion Center
Conditions:
Breast Cancer
Proton Therapy
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
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-yea...
Eligibility Criteria
Inclusion
- Age ≥ 40 years
- Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma
- Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm)
- No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT
- No prior radiation therapy to the ipsilateral chest or breast
- ECOG 0 \~ 2 or KPS ≥ 70
Exclusion
- Without pathology diagnosis
- Positive margins or close margins (\< 2mm)
- Lymph nodes or distant metastasis
- Bilateral breast cancer or patients with a history of contralateral breast cancer
- Prior radiation therapy to the ipsilateral chest or breast
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2029
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT07135661
Start Date
October 10 2024
End Date
October 31 2029
Last Update
August 22 2025
Active Locations (1)
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1
Shanghai Proton and Heavy Ion Center
Shanghai, China