NCT06383663Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 452 (estimated)
- First submitted
- 21 Apr 2024
- Start date
- 1 May 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06383663
What you commit to
- Study type: Interventional
- Planned participants: 452
- From 1 May 2024 to the primary completion date, 31 Dec 2028
- No sites listed in no 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
- En-bloc resection cannot be achieved;
- Previous history of other tumors or combined with other tumors;
Other illness
- Patients with heart, lung, vascular and other diseases cannot receive antitumor therapy;
- Pregnant, lactating or inflammatory breast cancer patients;
- Diseases associated with immune, endocrine or cardiovascular systems;
Other
- The range of metastasis exceeds the neck IV and VB region;
- Preoperative examination found distant metastasis;
- Refusing to comply with the study protocol and refusing to sign the informed consent
Who the study is looking for
- 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;
- Supraclavicular lymph node metastasis was confirmed by pathology;
- Consent to receive biopsy of breast cancer and supraclavicular lymph node tissue;
- Patients with primary breast cancer have no history of malignant tumors and have not received chemotherapy, radiotherapy or endocrine therapy;
- Have at least one measurable target lesion according to RECIST criteria;
- ECOG score ≦ 1;
- 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;
- No distant metastases were found in preoperative imaging examination of whole abdominal color ultrasound, chest CT or MRI, bone scan, or PET/CT;
- normal mind, can cooperate to complete the treatment;
- Expected survival ≥36 months
- 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.
Age in the registry: 35 years to 65 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.