NCT07385365

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 the efficacy and toxicities of radiotherapy are evaluated.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,142

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
202mo left

Started Feb 2026

Longer than P75 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Feb 2026Dec 2042

First Submitted

Initial submission to the registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2042

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

6.9 years

First QC Date

January 27, 2026

Last Update Submit

February 9, 2026

Conditions

Breast Cancer

Keywords

Breast Cancerintermediate-risk

Outcome Measures

Primary Outcomes (1)

  • tumor-free survival rate

    5 year

Secondary Outcomes (4)

  • localregional recurrence

    5 year

  • overall survival

    5 year

  • acute toxicity

    6 months

  • late complication

    5 year

Study Arms (2)

Regional nodal irradiation

EXPERIMENTAL

woman with intermediate-risk Breast Cancer involve postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region

Radiation: Regional nodal Radiotherapy

Non-Regional nodal irradiation

ACTIVE COMPARATOR

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.

Radiation: Non-Regional nodal Radiotherapy

Interventions

Regional nodal RadiotherapyRADIATION

postoperative conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall and nodal region

Regional nodal irradiation
Non-Regional nodal RadiotherapyRADIATION

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 irradiation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital,Chinese Academy od Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Shu-Lian Wang, M.D.

CONTACT

+86-010-87787659wangsl@cicam.ac.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2042

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)