Status:
UNKNOWN
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Hebei Medical University Fourth Hospital
Shanghai Zhongshan Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy.
Detailed Description
Eligible patients are randomized into 2 groups: chest wall and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall and supraclavicular nodal +-axillary nodal irrad...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group Performance Status Scale 0-2
- Histologically confirmed invasive breast cancer
- Underwent total mastectomy and axillary dissection(10 or more axillary lymph nodes detected) and negative margins
- Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1， IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy
- No supraclavicular or internal mammary nodes metastases based on images before system therapy
- No distant metastases
- Could tolerate radiotherapy
- Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles)
- Anticipated to receive endocrine therapy for 5 years if indicated
- Anticipated to receive anti-HER2 therapy for 1 years if indicated
- LVEF≥50% based on echocardiogram
- Willing to follow up
- Written,informed consent
Exclusion
- Simultaneous bilateral breast cancer
- Sentinel lymph node biopsy only without axillary dissection
- Had received internal mammary node dissection
- No imaging assessment of the internal mammary nodal before system therapy
- One-stage breast reconstruction
- Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease
- Had history of chest wall or supraclavicular radiotherapy
- Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04320979
Start Date
May 8 2020
End Date
May 1 2024
Last Update
January 11 2022
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021