Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive

Study Overview
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Brief Summary
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In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.

Detailed Description
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OBJECTIVES: Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan. Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive. Draw the learning curve of internal mammary sentinel lymph node biopsy. OUTLINE: 3 18 hours before surgery, under ultrasonographic guidance, 0.5 1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2 2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5 1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.

Official Title
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Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: IM-SLNB
* Radiation: 99mTc-SC
* Device: Histologic Examination
* Device: LSG
* Drug: Methylthioninium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary breast cancer clinically axilla-positive Exclusion Criteria: enlarged internal mammary nodes by imaging

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clinically positive axillary nodes<br>3 18 hours before surgery, under ultrasonographic guidance, 0.5 1.0 mCi 99mTc-SC in sterile saline (total volume 0.2 2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5 1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination | Procedure: IM-SLNB<br>* IM-SLNB is performed according to the pre-operative lymphoscintigraphy<br>* Other names: Internal Mammary Sentinel Lymph Node Biopsy;Radiation: 99mTc-SC<br>* Two syringes of 0.25 0.5 mCi 99mTc-SC in 0.2 1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.<br>* Other names: 99mTc-labeled Sulfur Colloid;Device: Histologic Examination<br>* All IMSLNs were analyzed by histologic examination for future therapy planning.<br>* Other names: hematoxylin-eosin staining and immunohistochemistry;Device: LSG<br>* lymphoscintigraphy was performed 0.5 1.0 hour before surgery<br>* Other names: Lymphoscintigraphy;Drug: Methylthioninium<br>* Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB | Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization Rate of IMSLNs | visualization rate of internal mammary hotspots in lymphoscintigraphy | 1 year | 
| Metastasis Rate of IMSLNs | Metastasis Rate of internal mammary sentinel lymph node | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Clinically Axillary Node -Positive, Sentinel Lymph Node Biopsy, Internal Mammary