A Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer
Starting soon · Phase 3
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07385365
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 3142
- Starts
- 2026-02-01
- Expected to finish
- 2042-12-31
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Cancer Hospital,Chinese Academy od Medical Sciences — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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