Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
This is a pilot study at the National Cancer Institute (INT) of Milan evaluated the feasibility of selective axillary dissection (SAD) which preserved the lymphatic drainage of the arm. Lymph nodes draining the arm are identified following radiotracer injection and lymphoscintigraphy, a technique called axillary reverse mapping (ARM). SAD was found feasible in 75% of patients. Furthermore only 9% had BCRL after SAD compared to 33% after axillary lymph node dissection (ALND).

Detailed Description
-----------------
To evaluate the efficacy, safety and cost reduction of SAD compared to standard ALND, we propose a prospective 2-arm randomised trial. The control arm consists of patients randomized to ALND, the study arm consists of patients randomized to SAD.

Official Title
-----------------
SELECTIVE AXILLARY LYMPH NODE DISSECTION VS COMPLETE AXILLARY DISSECTION: A RANDOMISED CLINICAL TRIAL TO ASSESS THE PREVENTION OF LYMPHEDEMA IN BREAST CANCER TREATMENT

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
* Procedure: COMPLETE AXILLARY DISSECTION (ALND)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with operable breast cancer who are candidates for ALND, irrespective of the type of breast surgery performed or adjuvant treatments administered. Patients who sign the informed consent form after explanation of trial aims by a senologist involved in the study. Patients able to attend INT for regular follow-up as required by study protocol. Exclusion Criteria: Massive axillary metastasis (N2 AJCC). Previous surgery to controlateral axillary region. Previous radiotherapy to ipsilateral or controlateral regional lymph nodes. Non compliance with any inclusion criterion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed study is a 2-arm (1:1 allocation) prospective randomised trial. The control arm consists of patients randomized to ALND, the study arm is patients randomized to SAD.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)<br> | Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)<br> <br> |
| Active Comparator: COMPLETE AXILLARY DISSECTION (ALND)<br> | Procedure: COMPLETE AXILLARY DISSECTION (ALND)<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND) | For this purpose patients enrolled will receive a physical assessment one month after surgery, with evaluation at 6 and 12 months after surgery that includes oncological assessment, physical assessment, lymphoscintigraphy, and self-evaluation questionnaire to assess the presence BCRL. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the selective axillary dissection (SAD) procedure by assessing the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes. | to assess the potential for residual disease in the axilla after SAD by evaluating the status, in the ALND arm, of nodes that are spared and assess the occurrence of axillary relapses during follow-up due to incomplete resection of axillary lymph nodes. | 36 months |