OncoMatch/Clinical Trials/NCT07805538
Response-Adapted Omission of Nodal Boost In N3 Breast Cancer After Neoadjuvant Therapy
Is NCT07805538 recruiting? Yes, currently enrolling (Sep 2026). This NA trial studies non-drug interventions for breast cancer.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage CN3A, CN3B, CN3C (other)
Excluded: Stage IV
cN3 disease, defined according to AJCC 8th staging system, confirmed by imaging and/or pathology
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: neoadjuvant systemic therapy
Completion of NST. Standard-of-care regimens must include at least four cycles of chemotherapy; Anti-HER2 targeted therapy is mandatory for HER2-positive disease, and immunotherapy may be added for eligible triple-negative breast cancer (TNBC). Clinical trial regimens are permitted per protocol, with or without chemotherapy, including novel agents (e.g., antibody-drug conjugates [ADCs], immunotherapies, anti-angiogenics, PARP inhibitors, or other investigational drugs). Both pathways are accepted provided the full protocol-specified course is completed.
Cannot have received: radiotherapy to the breast, chest wall, or regional nodes
Prior radiotherapy to the breast, CW, or regional nodes
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07805538 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiotherapy to the breast, chest wall, or regional nodes disqualifies patients from enrollment.
What disease stage is eligible?
Stage CN3A or CN3B or CN3C is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages