Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: moderate hypofractionated proton radiotherapy, ultra-hypofractionated proton radiotherapy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Proton Therapy. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Phase II Randomized Controlled Trial Comparing Ultra-Hypofractionated and Moderately Hypofractionated Proton Radiotherapy Following Breast-Conserving Surgery in Early-Stage Breast Cancer（UPH-BC）
Overview
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.
Interventions
- Radiation moderate hypofractionated proton radiotherapy
moderate hypofractionated proton radiotherapy: Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE) - Radiation ultra-hypofractionated proton radiotherapy
Ultra-hypofractionated proton radiotherapy:Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions.
Primary outcome measures
- Cosmetic Outcomes [Time frame: 2 years]
Secondary outcome measures (4)
- Acute and late toxicities [Time frame: 5 years]
- Locoregional recurrence (LRR) [Time frame: 5 years]
- Disease-free survival (DFS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Proton and Heavy Ion Center — Shanghai
Identifiers
NCT: NCT07135661 · SPHIC-TR-BCa2024-02