Clinical trial · Interventional
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
NCT04320979CI-TRIAL-00100752active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| internal mammary nodal irradiation | Radiation | — | UNRESOLVED |
| no internal mammary nodal irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- internal mammary nodal irradiation
- description
- chest wall/whole breast and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
- interventionNames
- Radiation: internal mammary nodal irradiation
- type
- ACTIVE_COMPARATOR
- label
- no-internal mammary nodal irradiation
- description
- ipsilateral chest wall/whole breast and supraclavicular +-axillary nodal irradiation
- interventionNames
- Radiation: no internal mammary nodal irradiation
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDZhao XR, Fang H, Tang Y, Hu ZH, Jing H, Liang L, Yan XN, Song YW, Jin J, Liu YP, Chen B, Tang Y, Qi SN, Li N, Lu NN, Men K, Hu C, Zhang YH, Li YX, Wang SL. POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial. BMC Cancer. 2021 Nov 6;21(1):1185. doi: 10.1186/s12885-021-08852-y. PMID 34742270