Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer

NCT07179744 | Recruiting DMC

• 1 other identifier: REOM
• Study Type: observational
• Target: 635
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether certain patients can safely omit regional lymph node radiotherapy. These women must have hormone-sensitive, Her2-negative tumors, have 1-3 positive axillary nodes and have RecurIndex low-risk.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Local-regional recurrence rate

  defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred

  5 years

Secondary Outcomes (8)

• Any first recurrence (AFR)

  5 years

• Local-regional recurrence free survival (LRFS)

  5 years

• Recurrence free survival (RFS)

  5 years

• Disease free survival (DFS)

  5 years

• Beast cancer specific mortality (BCSM)

  5 years

Study Arms (1)

Node Positive Breast Carcinoma

Omission of Regional Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pT1-2N1M0 breast cancer

You may qualify if:

• Age ≥ 18 years old, ≤ 70 years old.
• Eastern Cooperative Oncology Group (ECOG) ≤ 2.
• Postoperative pathology is clearly diagnosed as invasive breast cancer. Meet the clinical definition of low risk: ①Axillary lymph node micrometastasis (N1mic) or ②N1 patients who meet the following conditions at the same time,
• a）Age ≥ 40 years old, b）Vascular tumor thrombus (LVI) negative or allow few positive LVI (excluding extensive or massive LVI), c）ER positive (ER ≥ 1%) and HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH).
• Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1).
• The patient must have sufficient primary fresh frozen specimens or post- paraffin tissue sections for RecurIndex testing.
• Patients must have RecurIndex low risk obtained from testing of breast tumor tissue from a core biopsy or from the surgical specimen.
• The primary tumor and breast undergo breast-conserving surgery or total resection ± breast reconstruction (autologous/prosthetic).
• There must be adequate systemic examination (such as chest X-ray, B- ultrasound, CT, etc.) within 3 months before randomization of radiotherapy to confirm that there is no distant metastasis.
• Preoperative or radiotherapy should be performed within 12 months of randomization and must have mammography and/or MRI to confirm that there is no contralateral breast cancer.
• At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery.
• Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy.
• No previous history of malignant tumors, except for basal cell carcinoma of the skin.
• Signed an informed consent form.

You may not qualify if:

• Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment.
• Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy.
• Patients who underwent total mastectomy and only sentinel lymph node biopsy.
• Have a history of contralateral breast cancer.
• History of chest radiotherapy.
• combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness.
• History of autoimmune diseases such as scleroderma or active lupus erythematosus.
• pregnant and lactating patients.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Sun Yat-sen University: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yuting Tan

CONTACT

8615913198466; tanyt3@mail.sysu.edu.cn

Xiaobo Huang

CONTACT

8613556080080; huangxb@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 18, 2025
• Study Start: July 6, 2022
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 5, 2032
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)