Ultra-Hypofractionated vs. Moderately Hypofractionated Proton Therapy for Early Breast Cancer After Lumpectomy

NCT07135661 | Recruiting

• 1 other identifier: SPHIC-TR-BCa2024-02
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Proton Therapy

Keywords

Ultra-Hypofractionated Irradiation; Moderately Hypofractionated Irradiation; Breast Cancer; Proton Therapy

Outcome Measures

Primary Outcomes (1)

• Cosmetic Outcomes

  Cosmetic outcomes will be assessed at 2 years after radiotherapy. Changes in breast appearance compared to baseline will be evaluated using the Breast Cancer Treatment Outcome Scale (BCTOS), independently completed by the patient, the treating physician, and a trained research assistant at each follow-up visit. Standardized photographs of the treated breast will be taken at each assessment time point and analyzed using BCCT.core software for objective cosmetic scoring.

  2 years

Secondary Outcomes (4)

• Acute and late toxicities

  5 years

• Locoregional recurrence (LRR)

  5 years

• Disease-free survival (DFS)

  5 years

• Overall survival (OS)

  5 years

Other Outcomes (1)

• Quality of Life, as measured by EORTC QLQ-BR23 questionnaire

  1 years

Study Arms (2)

moderate hypofractionated proton radiotherapy

ACTIVE COMPARATOR

Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE)

Radiation: moderate hypofractionated proton radiotherapy

ultra-hypofractionated proton radiotherapy

EXPERIMENTAL

Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions.

Radiation: ultra-hypofractionated proton radiotherapy

Interventions

moderate hypofractionated proton radiotherapy RADIATION

moderate hypofractionated proton radiotherapy: Whole Breast Irradiation, at 40 Gy(RBE) in 15 fractions, tumor bed SIB to 48Gy(RBE)

moderate hypofractionated proton radiotherapy

ultra-hypofractionated proton radiotherapy RADIATION

Ultra-hypofractionated proton radiotherapy:Whole breast radiotherapy, 26 Gy(RBE) in 5 fractions，tumor bed boost with 10Gy(RBE) in 2 fractions.

ultra-hypofractionated proton radiotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Proton and Heavy Ion Center: lead

Study Sites (1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ping Li

CONTACT

+86 02138296666; ping.li@sphic.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 22, 2025
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2029
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

CN (1)