Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Sarah L. Blair (ucsd)

Description

Summary

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Official Title

ARM: Axillary Reverse Mapping - A Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection With and Without Axillary Reverse Mapping

Details

PRIMARY OBJECTIVES: I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping [ARM]) versus Group II (ARM). SECONDARY OBJECTIVES: I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics. III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM. EXPLORATORY OBJECTIVES: I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND). GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I. After completion of study, patients are followed up for 3 years.

Keywords

Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Neoplasms Lymphedema Isosulfan Blue Axillary Lymph Node Dissection Mapping Quality-of-Life Assessment ALND

Eligibility

For females ages 18 years and up

Inclusion Criteria:

  • Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions:
  • Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
  • Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
  • Patients will be staged according to the TNM staging system.
  • Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.

o Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.

  • No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ [DCIS]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration).
  • No bilateral invasive breast cancer.
  • No matted nodes.
  • No history of lymphedema of either arm.
  • No known allergies blue dyes, including make-up containing blue dye.
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
  • Female :

Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  • Creatinine: =< 1.5 x upper limit of normal (ULN).

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Saint John's Cancer Institute accepting new patients
    Santa Monica California 90404 United States
  • Alta Bates Summit Medical Center - Summit Campus currently not accepting new patients, but might later
    Oakland California 94609 United States
  • Contra Costa Regional Medical Center accepting new patients
    Martinez California 94553-3156 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alliance for Clinical Trials in Oncology
ID
NCT03927027
Phase
Phase 3 Breast Cancer Research Study
Study Type
Interventional
Participants
Expecting 516 study participants
Last Updated