Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection
a study on Breast Cancer Lymphedema
Summary
- Eligibility
- for females ages 18 years and up (full criteria)
- Location
- at UCSD
- Dates
- study startedcompletion around
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:
- 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:
- 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:
- 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
La Jolla California 92093 United States - Saint John's Cancer Institute
Santa Monica California 90404 United States - Alta Bates Summit Medical Center - Summit Campus
Oakland California 94609 United States - Contra Costa Regional Medical Center
Martinez California 94553-3156 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Alliance for Clinical Trials in Oncology
- ID
- NCT03927027
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- About 534 people participating
- Last Updated