N/A N=13 Diagnostic

Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Breast Cancer · Axillary Lymph Node Dissection

Bottom Line

View on ClinicalTrials.gov: NCT00717886 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast). — 0 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: isosulfan blue dye (Radiation)
Age: Adult, Older Adult · 21+ yrs
Sex: Female
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).	—	—

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.

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)

View full record on ClinicalTrials.gov →

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.