Upper Extremity Lymphatic Mapping for Breast Cancer Patients

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.

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Key information

Conditions

Breast Cancer Axillary Lymph Node Dissection Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

isosulfan blue dye

Radiation

At the time of surgery, each patient will undergo a subareolar injection of isosulfan blue dye into the ipsilateral breast as routinely performed during a sentinel lymph node mapping for breast cancer. The surgeon will then perform an axillary lymph node dissection in the usual, routine manner. The above differs from standard of care in that patients scheduled for an upfront axillary dissection do not routinely undergo sentinel lymph node mapping- therefore these patients would not normally get any isotope or TSC injections since they already need an ALND. Second, standard sentinel lymph node mapping involves injection of TSC into the affected breast the day prior to surgery or 3 hours before surgery versus injection of TSC into the ipsilateral upper extremity. The protocol specifies "day of" mapping for patient convenience.

Other names: Once the specimen is removed from the patient, the axillary nodes will be, dissected from the specimen and categorized: "blue only"; "radioactive only";, "blue and radioactive"; and "neither." The number of axillary nodes which are, "radioactive only" will indicate the nodes which drain the ipsilateral upper, extremity. The "blue and radioactive" nodes will indicate the sentinel lymph, nodes from the breast, which are also nodes that drain the ipstilateral upper, extremity. The prevalence of positive "radioactive only" and /or "blue and, radioactive", "blue only" and nodes with "neither" will be noted.

Primary outcomes

Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).

Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Upper Extremity Lymphatic Mapping for Breast Cancer Patients: A Pilot Study

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jul 18, 2008
Registry last updated: Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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