RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer
- Conditions
- Breast CancerRadiation
- Interventions
- Radiation: regional nodal irradiationRadiation: WBIRadiation: chestwall XRT
- Registration Number
- NCT04069884
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 540
- 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).
- 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 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.
- No contralateral breast cancer must be confirmed by molybdenum target and/or MRI within 12 months before randomization of radiotherapy.
- 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.
- The patient must have sufficient primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing.
- No previous history of malignant tumors, except for basal cell carcinoma of the skin.
- Signed an informed consent form.
- 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.
- Unable or unwilling to sign an informed consent form.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (Clinical low-risk, RecurIndex high-risk) regional nodal irradiation Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively. Arm I (Clinical low-risk, RecurIndex high-risk) WBI Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively. Arm I (Clinical low-risk, RecurIndex high-risk) chestwall XRT Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively. Arm II (Clinical low-risk, RecurIndex high-risk) WBI No Regional nodal irradiation (RNI) , whole breast irradiation (WBI) for breast-conserving patients and No Chest wall irradiation (CWI) for total mastectomy patients.
- Primary Outcome Measures
Name Time Method Invasive disease-free survival (IDFS) 5 years defined as the time between randomization and either local recur, distant metastases or death occurred
- Secondary Outcome Measures
Name Time Method Disease free survival (DFS) 5 years defined as time between randomization and the time of disease recur or death occur
Distant metastasis free survival (DMFS) 5 years defined as time between randomization and the time of distant metastases, or death occurred
Recurrence free survival (RFS) 5 years defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Beast cancer specific mortality (BCSM) 5 years defined as time between randomization and the time of death occur specific due to breast cancer
Patient life quality measurement 5 years At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Breast-23 (BR23)
Any first recurrence (AFR) 5 years defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology
Local-regional recurrence free survival (LRFS) 5 years defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Overall Survival (OS) 5 years defined as time between randomization and the time of death occurred
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China