Clinical trial NCT01668914: Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Official title: Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Clinically Axillary Node -Positive
Sentinel Lymph Node Biopsy
Internal Mammary
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
First posted: 2012-08-20
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* primary breast cancer
* clinically axilla-positive

Exclusion Criteria:

* enlarged internal mammary nodes by imaging

Primary outcomes:
measure: Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
timeFrame: 1 year
Secondary outcomes:
measure: Visualization Rate of IMSLNs
timeFrame: 1 year
measure: Metastasis Rate of IMSLNs
timeFrame: 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute
name: Yong-sheng Wang, MD
role: STUDY_CHAIR
affiliation: Shandong Cancer Hospital and Institute
name: Peng-fei Qiu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Cancer Hospital and Institute
name: Yan-bing Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: