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A Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer Phase 3 3,142

Not yet recruiting
Clinical Trial NCT07385365 is designed to study Treatment for Breast Cancer. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on February 1, 2026 until the study accrues 3,142 participants. Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, this study is expected to complete by December 31, 2042. The latest data from ClinicalTrials.gov was last updated on February 11, 2026.
Brief Summary
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 th...Show More
Official Title

A Phase Ⅲ Randomized Clinical Study and Real World Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer

Conditions
Breast Cancer
Other Study IDs
  • NCC4876
NCT ID Number
NCT07385365
Start Date (Actual)
2026-02-01
Last Update Posted
2026-02-11
Completion Date (Estimated)
2042-12-31
Enrollment (Estimated)
3,142
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Breast Cancer
intermediate-risk
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRegional nodal irradiation
woman with intermediate-risk Breast Cancer involve postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
Regional nodal Radiotherapy
postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region
Active ComparatorNon-Regional nodal irradiation
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.
Non-Regional nodal Radiotherapy
conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
tumor-free survival rate
5 year
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
localregional recurrence
5 year
overall survival
5 year
acute toxicity
6 months
late complication
5 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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.

  • 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)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences logoCancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Responsible Party
Shulian Wang,MD, Principal Investigator, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Central Contact
Contact: Shu-Lian Wang, M.D., +86-010-87787659, [email protected]
1 Study Locations in 1 Countries

Beijing Municipality

Cancer Hospital,Chinese Academy od Medical Sciences, Beijing, Beijing Municipality, China
Shulian Wang, M.D., Contact, +86-010-87787659, [email protected]