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.

Phase 2

Terminated

Conditions: Recurrent Breast Cancer
Stage IA Breast Cancer
Stage II Breast Cancer
Lymphedema
Stage IB Breast Cancer

Interventions: Radiation: technetium Tc 99m sulfur colloid
Drug: methylene blue
Drug: indocyanine green solution
Procedure: sentinel lymph node biopsy
Procedure: axillary lymph node biopsy
Procedure: bioimpedance spectroscopy
Procedure: quality-of-life assessment
Other: lymphedema management

Registration Number: NCT01276054

Lead Sponsor: University of Southern California

Brief 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

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 4

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SNB plus ARM or ALND (+/- SNB) plus ARM	indocyanine green solution	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 an axillary reverse mapping.
SNB plus ARM or ALND (+/- SNB) plus ARM	quality-of-life assessment	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 an axillary reverse mapping.
SNB plus ARM or ALND (+/- SNB) plus ARM	lymphedema management	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 an axillary reverse mapping.
SNB plus ARM or ALND (+/- SNB) plus ARM	axillary lymph node biopsy	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 an axillary reverse mapping.
SNB plus ARM or ALND (+/- SNB) plus ARM	technetium Tc 99m sulfur colloid	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 an axillary reverse mapping.
SNB plus ARM or ALND (+/- SNB) plus ARM	sentinel lymph node biopsy	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 an axillary reverse mapping.
SNB or ALND (+/- SNB)	sentinel lymph node biopsy	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.
SNB or ALND (+/- SNB)	bioimpedance spectroscopy	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.
SNB plus ARM or ALND (+/- SNB) plus ARM	bioimpedance spectroscopy	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 an axillary reverse mapping.
SNB or ALND (+/- SNB)	indocyanine green solution	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.
SNB or ALND (+/- SNB)	axillary lymph node biopsy	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.
SNB or ALND (+/- SNB)	technetium Tc 99m sulfur colloid	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.
SNB or ALND (+/- SNB)	quality-of-life assessment	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.
SNB plus ARM or ALND (+/- SNB) plus ARM	methylene blue	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 an axillary reverse mapping.
SNB or ALND (+/- SNB)	methylene blue	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.

Primary Outcome Measures

Name	Time	Method
Whether or Not a Patient Has Developed Grade 1+ LE	During the first year post-operatively	LE is defined using the CTCAE v3 definition: a \>5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.

Secondary Outcome Measures