IMI group / omit of IMI group / Breast Cancer · Interventional Study

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

ClinicalTrials.gov · August 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 recruiting interventional study comparing omission versus inclusion of internal mammary irradiation in women with early-stage intermediate-risk (N1) breast cancer, using a clinical-genomic model to identify candidates for IMI omission. No results are currently available in this registry record.

What was studied

Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer; Female; age from 18 Years; to 80 Years. Intervention: experimental group. Compared with: controlled group — Active Comparator. n = 214. 1 site: China.

Key findings

Safety

No interim data, effect sizes, or outcome frequencies are available to assess efficacy or safety.

Who this may help

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

Plain-language summary

This is a recruiting clinical trial registry record with no results posted; it describes a planned interventional study comparing radiotherapy strategies in early-stage breast cancer.

Study design

As stated by the source record.

MethodsPrimary outcome measure: 2-year event-free survival (assessed at 2 years)

DesignInterventional, Randomized, Parallel, Open label, Treatment purpose

PopulationBreast Cancer; Female; age from 18 Years; to 80 Years

Sample size214

Interventionexperimental group

Comparatorcontrolled group — Active Comparator

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Estimated enrollment214

Primary outcome measure2-year event-free survival

Primary outcome timeframe2 years

Caveats

Results are not yet reported in this registry record; study is actively recruiting.
Phase not specified; blinding and allocation methods not described.
No interim data, effect sizes, or outcome frequencies are available to assess efficacy or safety.

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

moderate

Interventional study comparing two radiation approaches; phase not specified.

Directness

strong

Direct comparison of IMI omission versus IMI in relevant clinical population.

Consistency

insufficient

No results reported; cannot assess consistency with other evidence.

Risk of bias

insufficient

Blinding, allocation concealment, and other design details not specified in registry record.

Sample adequacy

moderate

Estimated enrollment 214 participants; adequacy depends on event rates not yet reported.

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 (NCT04517266). This is a study registration, not published results. Lead sponsor: Ruijin Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 214 participants (ESTIMATED). Conditions: Breast Cancer. Interventions: RADIATION: omit of IMI group; RADIATION: IMI group. Primary outcome measures: 2-year event-free survival , 2 years. Brief summary: The effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.

Follow from this

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

NCT04517266IMI groupRuijin Hospitalomit of IMI groupBreast Cancer