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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: COMPLETE AXILLARY DISSECTION (ALND); Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT03083314

RF-2013-02355260

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

Experimental group

Treatment:

Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

COMPLETE AXILLARY DISSECTION (ALND)

Active Comparator group

Treatment:

Procedure: COMPLETE AXILLARY DISSECTION (ALND)