Clinical trial · Interventional
Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
NCT05976412CI-TRIAL-00068617recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chest/whole breast irradiation | Radiation | — | UNRESOLVED |
| Regional lymph node radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RNI group
- interventionNames
- Radiation: Regional lymph node radiotherapy
- Radiation: chest/whole breast irradiation
- type
- PLACEBO_COMPARATOR
- label
- non-RNI group
- interventionNames
- Radiation: chest/whole breast irradiation
Primary outcomes (1)
- measure
- 5 year disease free survival rate
- timeFrame
- 5 year
- description
- Disease free survival rate from randomization to 5 years after radiotherapy
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Voluntarily participate and sign an informed consent form; Age\>18 years old, female; received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection; Invasive cancer, postoperative axillary lymph node negative, with pathological staging of T1-3N0M0 stage (Stage IA, IIA, IIB); including two or more high-risk factors based on four clinical high-risk recurrence factors \[tumor size (\>2cm), tumor site (medial and central quadrants), Ki-67 level (\>14%), and vascular status (positive)\]; KPS ≥ 80, estimated survival time \>5 years; Complete healing of Surgical incision, no incision infection, etc; Reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study Exclusion Criteria: Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; History of malignant tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ); Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
References
Publications (1)
- DERIVEDQi WX, Ou D, Cao L, Li S, Zhang S, Cai R, Xu C, Cai G, Chen J. The PRINCE-BC trial: precision regional irradiation of nodal stations for clinical evaluation of high-risk pN0 breast cancer - a phase III, open-label, randomized controlled trial. BMC Cancer. 2026 Apr 7;26(1):618. doi: 10.1186/s12885-026-15971-x. PMID 41947078