N/A
Completed N=13
Upper Extremity Lymphatic Mapping for Breast Cancer Patients
Breast Cancer · Axillary Lymph Node Dissection
Source: ClinicalTrials.gov NCT00717886 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). — 0 participants
Summary
This study is being done to see if lymph nodes that drain the arm also drain the breast. An axillary lymph node dissection removes lymph nodes under the arm. It is done to help prevent cancer cells from spreading to the rest of the body. Usually, about 12 to 15 nodes are removed. They are then examined to see if they have cancer cells. Removing these lymph nodes has some side effects. The most common is lymphedema. This is the build-up of fluid in the arm. This study will tell us if it may be possible in the future to identify lymph nodes that just drain the arm. Leaving those nodes may help to reduce the rate of lymphedema for future patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). |
— | — |
Eligibility Criteria
Inclusion Criteria
- Females with Stage II invasive breast cancer and documented axillary metastases by core biopsy, clinical examination, or fine-needle aspiration who are scheduled to undergo an ALND.
- Females > 21 years of age
Exclusion Criteria
- Prior ipsilateral axillary surgery
- Prior ipsilateral axillary radiation
- Prior ipsilateral breast cancer
- Prior ipsilateral breast radiation
- Allergy to isosulfan blue dye
- History of ipsilateral upper extremity lymphedema
- Prior history of surgical excision of the upper outer quadrant of the ipsilateral breast
- Prior history of neoadjuvant chemotherapy for current breast cancer
- Bulky axillary disease at presentation (N2)
Data sourced from ClinicalTrials.gov (NCT00717886). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.