Ultra‑ vs moderately hypofractionated proton therapy after lumpectomy for early breast cancer
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）
Run by Shanghai Proton and Heavy Ion Center · NCT07135661 · Data updated 2026-11-12
This compares a very short (5-session) proton radiation schedule to a moderate (15-session) proton schedule for women 40 and older after lumpectomy for early-stage breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | Women only |
| Enrollment | 312 (estimated) |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | October 10, 2024 |
| Main results expected | October 31, 2027 |
| Study ends | October 31, 2029 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT07135661 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 40 or older with unilateral invasive breast cancer who had lumpectomy with negative margins (≥2 mm), pathologic stage pT1‑2N0M0, no prior ipsilateral chest radiotherapy, and performance status ECOG 0–2 (or KPS ≥70).
✕Probably not a fit
Patients with positive or close margins (<2 mm), node‑positive or metastatic disease, bilateral or prior contralateral breast cancer, prior ipsilateral radiotherapy, pregnancy, or lactation are unlikely to be eligible or to benefit from the regimens tested.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
After breast-conserving surgery, eligible patients receive whole-breast proton irradiation using either an ultra-hypofractionated schedule (five fractions over one week) or a moderately hypofractionated schedule (fifteen fractions over three weeks). Treatments are delivered at the Shanghai Proton and Heavy Ion Center and patients are followed for local control, radiation-related side effects, and cosmetic outcomes. The design directly compares toxicity profiles, cosmetic results, and recurrence rates between the two fractionation approaches. The trial excludes patients with positive/close margins, node-positive or metastatic disease, prior ipsilateral radiotherapy, bilateral disease, or pregnancy.
Why it matters
Potential benefit: If successful, it could allow many women to complete whole-breast radiation in one week with similar cancer control and potentially reduced heart and lung exposure because of proton delivery.
How similar studies have gone: Large photon trials (FAST, FAST‑Forward) showed similar local control, toxicity, and cosmetic outcomes for ultra‑hypofractionated versus moderately hypofractionated whole‑breast irradiation, but proton-specific evidence for these fractionation schedules is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 40 years 2. Pathologically (cytologically or histologically) confirmed unilateral primary invasive breast carcinoma 3. Breast conserving surgery + sentinel lymph node biopsy/axillary lymph node dissection, pathological stage pT1-2N0M0，negative margins (≥ 2 mm) 4. No distant metastasis confirmed by CT, MRI, bone scan, and PET/CT 5. No prior radiation therapy to the ipsilateral chest or breast 6. ECOG 0 \~ 2 or KPS ≥ 70 Exclusion Criteria: 1. Without pathology diagnosis 2. Positive margins or close margins (\< 2mm) 3. Lymph nodes or distant metastasis 4. Bilateral breast cancer or patients with a history of contralateral breast cancer 5. Prior radiation therapy to the ipsilateral chest or breast 6. Pregnancy (confirmed by serum or urine β-HCG test) or lactation
Where it's running
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Shanghai Proton and Heavy Ion Center
Shanghai, China Recruiting
Study contacts
- Study coordinator: Ping Li
- Email: ping.li@sphic.org.cn
- Phone: +86 02138296666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.