RecruitingNCT07179744

Regional Radiotherapy Omission in Low-Risk Node Positive Breast Cancer

A Multicenter, Prospective, Observational Study of Regional Radiotherapy Omission in Node Positive Patients With RecurIndex Low-risk Breast Cancer

Sponsor

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

Enrollment

635 participants

Start Date

Jul 6, 2022

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria14

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 Criteria8

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.