Upper Extremity Lymphatic Mapping for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717886
• Other study ID #: 08-051
• Status: Completed
• Phase: N/A
• First received: July 16, 2008
• Last updated: October 19, 2015
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Axillary Lymph Node Dissection
• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• isosulfan blue dye
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Prevalence of Metastases of Blue Nodes in the ALND Specimen (Nodes Draining the Breast).		2 years	No

External Links

•   Memorial Sloan Kettering Cancer Center