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

Status
Active
Cancer Type
Breast Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Prevention
NCT ID
NCT03927027
Protocol IDs
A221702 (primary)
A221702
A221702
NCI-2018-02445
Study Sponsor
Alliance for Clinical Trials in Oncology

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.

Objectives

PRIMARY OBJECTIVE:
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 OBJECTIVE:
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.

Eligibility

  1. 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 ultrasound (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.
  2. Prior Treatment: No prior axillary surgery on the ipsilateral side except needle biopsy or concurrent SLNB. * Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.
  3. 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).
  4. No bilateral invasive breast cancer.
  5. No matted nodes (by clinical exam).
  6. No history of lymphedema of either arm.
  7. No known allergies blue dyes, including make-up containing blue dye.
  8. In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
  9. 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
  10. Age >= 18 years
  11. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
  12. Creatinine: =< 1.5 x upper limit of normal (ULN).
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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