Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07805538 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusWithdrawn
PhaseNot applicable
Started2026-09-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
critical
Trial status changed: Recruiting → Withdrawn
Trial withdrawn: funding issues and poor accrual
Primary completion confirmed: September 2026 (last estimated July 2029)
Start date pushed: 2025-01-15 → 2026-09-01
624 trials monitored
See 9 trials at risk
5,180 trials monitored
See 256 trials at risk
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.
Trial Details
NCT Number NCT07805538
Lead Sponsor Fudan University
Conditions Breast Cancer
Start Date 2026-09-01
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-15