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)

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
China
Shanghai Proton and Heavy Ion Center
RECRUITING
Shanghai
Contact Information
Primary
Ping Li
ping.li@sphic.org.cn
+86 02138296666
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 312
Treatments
Active_comparator: moderate hypofractionated proton radiotherapy
Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE)
Experimental: ultra-hypofractionated proton radiotherapy
Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions,tumor bed boost with 10Gy(RBE) in 2 fractions.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Proton and Heavy Ion Center

This content was sourced from clinicaltrials.gov