3-week PBI / 1-week PBI / Early Stage Breast Cancer · Interventional Study

PBI for Low-risk Breast Cancer

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing phase 3 non-inferiority trial comparing 1-week versus 3-week partial breast irradiation regimens in early-stage breast cancer patients. No outcome data are reported in this registry entry; the study is actively recruiting and results are not yet available.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Early-Stage Breast Cancer; Female; age from 18 Years; to 75 Years. Intervention: 1-week PBI. Compared with: 3-week partial breast irradiation (PBI） — Active Comparator. n = 818. 1 site: China.

Key findings

Safety

No effect sizes, safety data, efficacy data, or quality-of-life comparisons available.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active recruitment registry record for a phase 3 non-inferiority trial with no results posted; it describes a planned study design and endpoints, not evidence of efficacy or safety.

Study design

As stated by the source record.

MethodsPrimary outcome measure: 3-year adverse cosmesis (assessed at 3 years)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationEarly-Stage Breast Cancer; Female; age from 18 Years; to 75 Years

Sample size818

Intervention1-week PBI

Comparator3-week partial breast irradiation (PBI） — Active Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment818

Primary outcome measure3-year adverse cosmesis

Intervention regimen 126 Gy/5 Fx (1-week PBI with IMRT)

Intervention regimen 240 Gy/15 Fx (3-week PBI with IMRT)

Caveats

No results reported; this is a registry record of a study still recruiting.
Blinding, randomization method, and allocation concealment not described in registry record.
No effect sizes, safety data, efficacy data, or quality-of-life comparisons available.
Study completion and results timeline not stated in source text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, randomized non-inferiority design appropriate for the research question.

Directness

strong

Primary endpoint (3-year adverse cosmesis) directly addresses clinical outcome of interest.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or other bias mitigation.

Sample adequacy

moderate

Planned enrollment 818 participants; adequate for phase 3, but study is still recruiting.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07814365). This is a study registration, not published results. Lead sponsor: Fudan University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 818 participants (ESTIMATED). Conditions: Early-Stage Breast Cancer. Interventions: RADIATION: 3-week PBI; RADIATION: 1-week PBI. Primary outcome measures: 3-year adverse cosmesis , 3 years. Brief summary: This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery. It also compares secondary outcomes including efficacy, safety, and quality of life between the two groups.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

3-week PBI1-week PBIFudan UniversityEarly Stage Breast CancerNCT07814365