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


N/A
21 Years
N/A
Not Enrolling
Female
Breast Cancer, Axillary Lymph Node Dissection

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number and prevalence of metastases of blue nodes in the ALND specimen (nodes draining the breast).

Outcome Time Frame:

conclusion of the study

Safety Issue:

No

Principal Investigator

Leslie Montgomery, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-051

NCT ID:

NCT00717886

Start Date:

June 2008

Completion Date:

October 2009

Related Keywords:

  • Breast Cancer
  • Axillary Lymph Node Dissection
  • Breast
  • Lymph Nodes
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021