Recruiting NCT06605521

To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients

— Observational Locally Advanced Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Subclavian lymph node dissection+radiotherapy, Simple clavicular region radiotherapy.
Who it may be relevant to: Registry conditions: Locally Advanced Breast Cancer. Basic parameters: 18 years — 80 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients: A Prospective, Multicenter, Non-interventionist Real World Study

Overview

For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.

Detailed description

The main endpoint of the study was recurrence free survival on the ipsilateral clavicle. The secondary study endpoint is disease-free survival; Ipsilateral supraclavicular relapse-free survival; Rregional lymph node relapse-free survival; Overall survival; Security; The incidence of upper limb lymphedema; Patient's quality of life.

Interventions

Procedure Subclavian lymph node dissection+radiotherapy
The patient grouping is determined jointly by the researchers and participants, and patients in Group A are selected for supraclavicular lymph node dissection and radiotherapy.
Procedure Simple clavicular region radiotherapy
If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.

Primary outcome measures

Intraclavicular recurrence free survival in group A patients [Time frame: 5th year after surgery]

Secondary outcome measures (7)

Disease-Free Survival [Time frame: 5th year after surgery]
Intraclavicular recurrence free survival in group B patients [Time frame: 5th year after surgery]
Regional lymph node recurrence free survival in group A/B patients [Time frame: 5th year after surgery]
Overall survival of patients in Group A/B [Time frame: 5th year after surgery]
Number of adverse events [Time frame: through study completion, an average of 2 year]
The incidence of upper limb lymphedema in group A/B patients at 2 years after surgery [Time frame: 2th year after surgery]
Patient's quality of life [Time frame: 2th year after surgery]

Eligibility criteria

Inclusion criteria

Female patients aged ≤ 80 years old.
ECOG score 0-1 points;
Breast cancer meets the following criteria: histologically diagnosed as invasive breast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed as ipsilateral supraclavicular lymph node metastasis (both cytology and histopathology);
Estimated patient survival time exceeding three months;
No obvious contraindications for surgery or radiotherapy;
The researcher judged that they were able to comply with the research protocol.
Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers not to affect the research protocol can be enrolled normally.
Voluntarily participate in this study and sign an informed consent form.

Exclusion criteria

Stage IV (metastatic) breast cancer;
Bilateral breast cancer;
Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;
History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy;
Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model: Case-control

Study locations

China · 1 center

Henan Cancer Hospital — Zhengzhou

Identifiers

NCT: NCT06605521 · 2023-122

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗