NCT07135661 Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy
| NCT ID | NCT07135661 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Proton and Heavy Ion Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 312 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 312 participants in total. It began in 2024-10-10 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07135661 clinical trial?
This trial is open to female participants only, aged 40 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07135661 currently recruiting?
Yes, NCT07135661 is actively recruiting participants. Contact the research team at ping.li@sphic.org.cn for enrollment information.
Where is the NCT07135661 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07135661 clinical trial?
NCT07135661 is sponsored by Shanghai Proton and Heavy Ion Center. The trial plans to enroll 312 participants.
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