RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

The purpose of this study is to validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.

Eligibility criteria

Qualifiers

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)Three subtypes are allowed (Lumina A, Lumina B/HER2 negative, Lumina B/HER2 positive) , namely ER positive (ER ≥ 1%), HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH) or ER positive (ER ≥ 1%), HER2 positive (3+ by IHC, or 2+ but positive by FISH).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • regional nodal irradiation
  • WBI
  • chestwall XRT

Treatment groups

540 Participants
are divided into 2 treatment groups

Sponsors and collaborators