Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Criteria


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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group I (ALND)
Patients receive isosulfan blue SC and undergo ALND.
  • Drug: Isosulfan Blue
    Given SC
  • Procedure: Axillary Lymph Node Dissection
    Undergo ALND
    Other names:
    • ALND
    • axillary dissection
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Group II (ARM, ALND)
Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
  • Drug: Isosulfan Blue
    Given SC
  • Procedure: Axillary Lymph Node Dissection
    Undergo ALND
    Other names:
    • ALND
    • axillary dissection
  • Procedure: Mapping
    Undergo ARM
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555-0565
Contact:
Site Public Contact
409-772-1950
clinical.research@utmb.edu

UTMB Cancer Center at Victory Lakes
League City, Texas 77573
Contact:
Site Public Contact
800-917-8906

More Details

NCT ID
NCT03927027
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

V. Suzanne Klimberg, MD, PhD
501-680-0779
Vsklimbe@utmb.edu

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.