Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

  • STATUS
    Recruiting
  • End date
    Jan 16, 2024
  • participants needed
    516
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 16 February 2021
Investigator
V. Suzanne Klimberg, MD, PhD
Primary Contact
Contra Costa Regional Medical Center (8.4 mi away) Contact
+52 other location
breast surgery
carcinoma
carcinoma in situ
breast carcinoma
invasive breast cancer
mastectomy
ductal carcinoma in situ
lobular carcinoma in situ
sentinel lymph node biopsy
isosulfan blue
lcis

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.

Description

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.

Details
Condition Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Treatment questionnaire administration, quality-of-life assessment, Axillary Lymph Node Dissection, Isosulfan Blue, Mapping
Clinical Study IdentifierNCT03927027
SponsorAlliance for Clinical Trials in Oncology
Last Modified on16 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Breast Cancer Stage III or Breast Cancer Stage I or Breast Cancer Stage II?
Do you have any of these conditions: Breast Cancer Stage II or Breast Cancer Stage III or Breast Cancer Stage I?
Do you have any of these conditions: Breast Cancer Stage I or Breast Cancer Stage III or Breast Cancer Stage II?
Do you have any of these conditions: Breast Cancer Stage I or Breast Cancer Stage III or Breast Cancer Stage II?
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
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)
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