Status:
RECRUITING
Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
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 ax...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 5 2032
Estimated Enrollment :
635 Patients enrolled
Trial Details
Trial ID
NCT07179744
Start Date
July 6 2022
End Date
July 5 2032
Last Update
September 18 2025
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120