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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorHenan Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial population

cT1-4N3M0 breast cancer

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Subclavian lymph node dissection+radiotherapy

    Procedure/Surgery

    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.

  • Simple clavicular region radiotherapy

    Procedure/Surgery

    If the patient chooses Group B treatment plan, they will receive simple clavicle area radiotherapy.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Subclavian lymph node dissection+radiotherapy group1 intervention
Group B: Simple clavicular region radiotherapy group1 intervention

Trial outcomes

Primary outcomes

1

Intraclavicular recurrence free survival in group A patients

The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up.

Time frame
5th year after surgery

Secondary outcomes

1

Disease-Free Survival

The time from surgery to the occurrence of recurrence, metastasis, or last follow-up.

Time frame
5th year after surgery
2

Intraclavicular recurrence free survival in group B patients

The time from surgery to ipsilateral supraclavicular fossa recurrence or last follow-up

Time frame
5th year after surgery
3

Regional lymph node recurrence free survival in group A/B patients

The time from surgery to the occurrence of regional lymph node recurrence, metastasis, or last follow-up

Time frame
5th year after surgery
4

Overall survival of patients in Group A/B

The time from surgery to patient death or last follow-up

Time frame
5th year after surgery

Other outcomes

Sponsors and contacts

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