Breast Cancer Clinical Trial

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Summary

Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

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Full Description

PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.

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Eligibility Criteria

Inclusion Criteria:

Stage 0, I, and II Breast Cancer
Not pregnant or breastfeeding
Breast cancer or prophylactic mastectomy requiring axillary nodal staging
Ability to read and/or comprehend consent form and questionnaires
Ability to follow-up per protocol
Unilateral axillary staging

Exclusion Criteria:

Stage 3
Previous axillary lymph node dissection
Neoadjuvant chemotherapy or hormonal therapy exceeding greater than 30 days duration
Allergy to blue dyes or iodine; NOTE: a non-blue dye or non-iodine-containing dye may be used in these patients
Patients with implanted medical devices such as a pacemaker may undergo perometry, but not BIS (Bioelectrical Impedance Spectroscopy)
Previous diagnosis of LE (lymphedema) of either extremity
Bilateral axillary staging

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT01276054

Recruitment Status:

Terminated

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States

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Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

4

Study ID:

NCT01276054

Recruitment Status:

Terminated

Sponsor:


University of Southern California

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