Clinical trial · Interventional
Supraclavicular Lymph Node Dissection for Ipsilateral Supraclavicular Lymph Node Metastatic Breast Cancer
A Prospective Multicenter Randomized Controlled Trial of the Prognostic Effects of Supraclavicular Lymph Node Dissection vs. No-dissection in Ipsilateral Supraclavicular Lymph Node Metastasis in Breast Cancer
NCT06383663CI-TRIAL-00076582not yet recruitingN/AClinicalTrials.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 was to compare the efficacy of surgical dissection of supraclavicular lymph nodes combined with radiotherapy versus radiotherapy alone in patients with ipsilateral supraclavicular lymph node metastasis.
Conditions
Conditions (2)
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 |
| Ipsilateral Supraclavicular Lymph Node Metastasis | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| Supraclavicular lymph node dissection combined with radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supraclavicular lymph node dissection combined with radiotherapy
- description
- Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive standard radiotherapy after supraclavicular lymph node dissection.
- interventionNames
- Procedure: Supraclavicular lymph node dissection combined with radiotherapy
- type
- PLACEBO_COMPARATOR
- label
- radiotherapy
- description
- Breast cancer patients with ipsilateral supraclavicular lymph node metastases receive only standard radiotherapy.
- interventionNames
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- DFS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Previously untreated primary breast cancer with supraclavicular lymph node metastasis or supraclavicular lymph node metastasis without other metastasis within 5 years after combined therapy; The diagnostic criteria refer to the diagnostic criteria for "primary breast cancer" and "Stage pN3c" in the AJCC Guidelines published on November 8, 2018; 2. Supraclavicular lymph node metastasis was confirmed by pathology; 3. Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue; 4. Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy; 5. Have at least one measurable target lesion according to RECIST criteria; 6. ECOG score ≦ 1; 7. The level of organ function must meet the following requirements: adequate bone marrow reserve: absolute counts of neutrophils (lobed and band neutrophils) ≥ 1.5×109/L, platelets ≥ 100×109/L, and hemoglobin ≥ 9 g/dL. Liver: Bilirubin \<1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3.0 times the upper limit of normal. Renal: Creatinine clearance ≥ 45 mL/min; 8. No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT; 9. normal mind, can cooperate to complete the treatment; 10. Expected survival ≥36 months 11. In accordance with the requirements of the Ethics Committee, there is an informed consent signed by the patient or her legal representative, or an informed consent signed by the patient and her family. Exclusion Criteria: 1. The range of metastasis exceeds the neck IV and VB region; 2. En-bloc resection cannot be achieved; 3. Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy; 4. Preoperative examination found distant metastasis; 5. Pregnant, lactating or inflammatory breast cancer patients; 6. Diseases associated with immune, endocrine or cardiovascular systems; 7. Previous history of other tumors or combined with other tumors; 8. Refusing to comply with the study protocol and refusing to sign the informed consent
References
Publications (5)
- BACKGROUNDRecht A, Gray R, Davidson NE, Fowble BL, Solin LJ, Cummings FJ, Falkson G, Falkson HC, Taylor SG 4th, Tormey DC. Locoregional failure 10 years after mastectomy and adjuvant chemotherapy with or without tamoxifen without irradiation: experience of the Eastern Cooperative Oncology Group. J Clin Oncol. 1999 Jun;17(6):1689-700. doi: 10.1200/JCO.1999.17.6.1689. PMID 10561205
- BACKGROUNDChen SC, Chen MF, Hwang TL, Chao TC, Lo YF, Hsueh S, Chang JT, Leung WM. Prediction of supraclavicular lymph node metastasis in breast carcinoma. Int J Radiat Oncol Biol Phys. 2002 Mar 1;52(3):614-9. doi: 10.1016/s0360-3016(01)02680-3. PMID 11849781
- BACKGROUNDChang XZ, Yin J, Sun J, Zhang XH, Cao XC. A retrospective study of different local treatments in breast cancer patients with synchronous ipsilateral supraclavicular lymph node metastasis. J Cancer Res Ther. 2013 Nov;9 Suppl:S158-61. doi: 10.4103/0973-1482.122514. PMID 24516053
- BACKGROUNDJung J, Kim SS, Ahn SD, Lee SW, Ahn SH, Son BH, Lee JW, Choi EK. Treatment Outcome of Breast Cancer with Pathologically Proven Synchronous Ipsilateral Supraclavicular Lymph Node Metastases. J Breast Cancer. 2015 Jun;18(2):167-72. doi: 10.4048/jbc.2015.18.2.167. Epub 2015 Jun 26. PMID 26155293
- BACKGROUNDLakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193. PMID 12111882