Omitting regional lymph node radiotherapy in low-risk node-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study enrolling women with invasive, hormone-sensitive, HER2-negative breast cancer who have 1–3 positive axillary nodes and a low RecurIndex score. Eligible patients (age 18–70, ECOG ≤2) meeting the specified pathology criteria will not receive regional nodal radiotherapy and will be followed over time. Outcomes of interest include regional recurrence, distant recurrence, overall survival, and treatment-related side effects. The goal is to compare cancer control and toxicity in this selected low-risk group to inform whether regional radiotherapy can be omitted safely.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Yuting Tan
• Email: tanyt3@mail.sysu.edu.cn
• Phone: 8615913198466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.