Clinical trial · Interventional
A Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer
A Phase Ⅲ Randomized Clinical Study and Real World Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer
- 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)
The research hypothesis is that the tumor-free survival rate of intermediate-risk breast cancer patients exempted from RNI is not inferior to that of those receiving RNI. Patients with intermediate-risk breast cancer have a relatively low local-regional recurrence rate whether they undergo RNI or not.Patients were randomly assigned to the RNI group and the non-RNI group.After radiotherapy,the patients are followed the efficacy and toxicities of radiotherapy are evaluated.
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 |
|---|---|---|---|
| Non-Regional nodal Radiotherapy | Radiation | — | UNRESOLVED |
| Regional nodal Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regional nodal irradiation
- description
- woman with intermediate-risk Breast Cancer involve postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
- interventionNames
- Radiation: Regional nodal Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Non-Regional nodal irradiation
- description
- woman with intermediate-risk Breast Cancer receive conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.
- interventionNames
- Radiation: Non-Regional nodal Radiotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 or above * Undergo breast-conserving surgery or total mastectomy and axillary lymph node dissection or sentinel lymph node biopsy * The surgical margin was negative * Tumor stage:Patients who receive direct surgery : pT1-2N1M0, with at least one lymph node having macrometastasis and a tumor risk score of 0-2.For those who underwent surgery after neoadjuvant chemotherapy: cT1-2N1-2M0→ypT0-2N0M0 (cN+ with pathological confirmation), neoadjuvant Chemotherapy for ≥6 cycles. Exclusion Criteria: * distant metastasis * metastasis of ipsilateral internal mammary, supraclavicular or subclavian lymph nodes * Had received chest radiotherapy in the past * Bilateral breast cancer * Pregnancy or lactation period * Other malignant tumors in the past or at the same time, and the tumor-free survival time is less than 5 years (excluding non-malignant melanoma skin cancer, papillary thyroid carcinoma/follicular carcinoma, cervical carcinoma in situ)
References
Publications (0)
Data not yet available