Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07385365

A Study of Postoperative Regional Nodal Radiotherapy in Intermediate-risk Breast Cancer

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Hospital,Chinese Academy od Medical Sciences

Beijing, Beijing Municipality, China

Location contact

Shulian Wang, M.D.

CONTACT

[email protected]

+86-010-87787659

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Regional nodal Radiotherapy

Radiation

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

Non-Regional nodal Radiotherapy

Radiation

conventional fraction/moderate hypofraction/ultrahypofraction radiotherapy to the whole breast/Chest Wall after breast-conserving surgery or receive no radiotherapy modified radical operation.

Primary outcomes

  1. tumor-free survival rate

    Time frame: 5 year

Secondary outcomes

  1. localregional recurrence

    Time frame: 5 year

  2. overall survival

    Time frame: 5 year

  3. acute toxicity

    Time frame: 6 months

  4. late complication

    Time frame: 5 year

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-Lian Wang, M.D.

CONTACT

[email protected]

+86-010-87787659

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2032
Study completion
2042
First posted
Feb 4, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.