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Response-Adapted Omission of Nodal Boost In N3 Breast Cancer After Neoadjuvant Therapy

NCT07805538 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 534

Last updated 2026-09-04

No results posted yet for this study

Summary

This is an open-label, multicenter, randomized phase 3 trial. Eligible patients are women with cN3 breast cancer who have completed neoadjuvant systemic therapy (NST), undergone breast/axillary surgery with the internal mammary, supraclavicular, and infraclavicular nodes left undissected, and have no macroscopic residual disease in these stations on post-NAT \[¹⁸F\]FDG PET-CT or other imagings. The primary endpoint is 3-year invasive breast cancer recurrence-free interval (IBCRFI). Secondary endpoints include locoregional recurrence-free survival, distant metastasis-free survival, disease-free survival, overall survival, toxicity, and patient reported outcomes. This trial will provide high-level evidence on the safety of nodal boost omission in cN3 breast cancer patients with clinical complete response after NST. If non-inferiority is confirmed, this strategy could establish a new, toxicity-sparing standard for regional nodal irradiation in this high-risk population.

Conditions

Interventions

RADIATION

Standard Boost.

a boost dose of 10 Gy in 5 fractions to initially involved but undissected nodal stations that achieved clincial complete response after neoadjuvant systemic therapy

RADIATION

Boost Omission

no boost to the initially involved but undissected nodal stations that achieved clinical complete response after neoadjuvant systemic therapy

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07805538 on ClinicalTrials.gov