Ultra‑ vs moderately hypofractionated proton therapy after lumpectomy for early breast cancer
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）
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07135661 on ClinicalTrials.gov |
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.
Who should consider this trial
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).
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Shanghai Proton and Heavy Ion Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Ping Li
- Email: ping.li@sphic.org.cn
- Phone: +86 02138296666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.