NCT04320979Active, not recruitingPhase 3
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients
Postmastectomy Prophylactic Internal Mammary Nodal Irradiation for High-risk Patients With Non-metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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 or breast-conserving surgery.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2400 (actual)
- First submitted
- 19 Mar 2020
- Start date
- 8 May 2020
- Primary completion date
- 1 Nov 2025
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04320979
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2400
- From 8 May 2020 to the primary completion date, 1 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had received internal mammary node dissection
- No imaging assessment of the internal mammary nodal before system therapy
- 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
Other illness
- Simultaneous bilateral breast cancer
- 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
Other
- Sentinel lymph node biopsy only without axillary dissection
- One-stage breast reconstruction
Who the study is looking for
- Eastern Cooperative Oncology Group Performance Status Scale 0-2
- Histologically confirmed invasive breast cancer
- Underwent total mastectomy/breast-conserving surgery 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
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.