Clinical trial NCT03716245: Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer
Official title: A Multicenter, Randomised, Open-label Prospective Clinical Trial to Evaluate the Clinical Significance of Supraclavicular Lymph Node Dissection for Breast Cancer Patients With Ipsilateral Supraclavicular Lymph Node Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Stage III
Keywords: breast cancer
supraclavicular lymph node
dissection
radiotherpy
prognosis
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 180
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. No concret guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis.

To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, the investigators randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.

Detailed description: Breast cancer is the most common cancer and the leading cause of deaths from cancer in women worldwide. Breast cancer patients with ipsilateral supraclavicular lymph node metastasis are defined as Ⅲc stage (N3) according to the newly published 8th AJCC TNM staging system. Clinical outcomes are similar for patients with ipsilateral supraclavicular lymph node metastases at first presentation and for patients with recurrent ipsilateral supraclavicular lymph node metastases. The survival rate was lower in patients with ipsilateral supraclavicular lymph node metastases than in patients with lower axillary or subclavian nodal involvement. No concrete guide line was supported to such patients. It is still pending whether to exert supraclavicular lymph node dissection to breast cancer patients with ipsilateral supraclavicular lymph node metastasis. Patients with ipsilateral supraclavicular lymph node metastases who were treated with surgery or radiotherapy and achieved good neck control were reported to achieve better survival than those for whom surgical treatment or irradiation did not result in good local control.

Patients with ipsilateral supraclavicular lymph node metastases should be offered a combined modality approach, including systemic therapy, surgery, and radiotherapy. Furthermore, local treatment, usually including axillary and supraclavicular lymph node, either by surgical clearance or by radical radiotherapy, can prevent the tumor cells from drainage, might be play a more important role. However, the role of surgical removal of the supraclavicular nodes is uncertain compared with radical radiotherapy. To our knowledge, the available literature comparing these two local treatments of ipsilateral supraclavicular lymph node metastases is scarce. Furthermore, the studies comparing the outcome of dissection of supraclavicular lymph node combined with local radiotherapy and radiotherapy of supraclavicular lymph node is also rare. All the related reports up to date have mixed them up.

To evaluate the clinical significance and complication of supraclavicular lymph node dissection for breast cancer patients with ipsilateral supraclavicular lymph node metastasis, we randomize patients into two groups, one group is supraclavicular lymph node dissection with radiotherapy group, the other group is radiotherapy group.

Therefore, in addition to investigating the role of surgical removal of the supraclavicular nodes in Chinese patients, we also try to reveal the potential difference between these two treatments, hoping to bring more insight into clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
2. Age≤75 years old, female;
3. Histologically confirmed breast cancer;
4. Histologically or cytologically confirmed ipsilateral supraclavicular lymph node metastasis；
5. cT0-T3；
6. low and moderate risk for anesthesia

Exclusion Criteria:

1. Absolute and relative contraindication for surgery or radiation；
2. existing distant metastasis before surgery；
3. non-invasive breast cancer；
4. with contralateral breast cancer；
5. Previous history of breast cancer or other malignancies；
6. ECOG≥2；
7. inflammatory breast cancer；
8. pregnancy；
9. any serious complications which caused patients not suitable to participate this study

Primary outcomes:
measure: Disease free survival
timeFrame: 3-5 years
Secondary outcomes:
measure: Occurring rate of complications
timeFrame: 3-5 years
measure: Overall survival
timeFrame: 3-5 years
measure: Life quality score
timeFrame: 3-5 years
measure: Recurrence free survival
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wu Xinhong
state: Hubei
Study officials:
affiliation: Hubei Cancer Hospital
name: Xinhong Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: