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

NCT03083314 | Completed

• 1 other identifier: RF-2013-02355260
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  36 months

Other Outcomes (1)

• To compare costs in the axillary lymph node dissection (ALND) and selective axillary dissection (SAD) arms

  36 months

Study Arms (2)

SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

EXPERIMENTAL

Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

COMPLETE AXILLARY DISSECTION (ALND)

ACTIVE COMPARATOR

Procedure: COMPLETE AXILLARY DISSECTION (ALND)

Interventions

SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD) PROCEDURE

SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

COMPLETE AXILLARY DISSECTION (ALND) PROCEDURE

COMPLETE AXILLARY DISSECTION (ALND)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Massive axillary metastasis (N2 AJCC).
• Previous surgery to controlateral axillary region.
• Previous radiotherapy to ipsilateral or controlateral regional lymph nodes.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Massimiliano Gennaro

Milan, 20133, Italy

Location

Related Publications (7)

• Gennaro M, Maccauro M, Sigari C, Casalini P, Bedodi L, Conti AR, Caraceni A, Bombardieri E. Selective axillary dissection after axillary reverse mapping to prevent breast-cancer-related lymphoedema. Eur J Surg Oncol. 2013 Dec;39(12):1341-5. doi: 10.1016/j.ejso.2013.09.022. Epub 2013 Oct 3.

  PMID: 24113621 RESULT

• Schunemann E Jr, Doria MT, Silvestre JB, Gasperin P Jr, Cavalcanti TC, Budel VM. Prospective study evaluating oncological safety of axillary reverse mapping. Ann Surg Oncol. 2014 Jul;21(7):2197-202. doi: 10.1245/s10434-014-3626-5. Epub 2014 Mar 6.

  PMID: 24599413 RESULT

• Agresti R, Martelli G, Sandri M, Tagliabue E, Carcangiu ML, Maugeri I, Pellitteri C, Ferraris C, Capri G, Moliterni A, Bianchi G, Mariani G, Trecate G, Lozza L, Langer M, Rampa M, Gennaro M, Greco M, Menard S, Pierotti MA. Axillary lymph node dissection versus no dissection in patients with T1N0 breast cancer: a randomized clinical trial (INT09/98). Cancer. 2014 Mar 15;120(6):885-93. doi: 10.1002/cncr.28499. Epub 2013 Dec 5.

  PMID: 24323615 RESULT

• Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.

  PMID: 21304082 RESULT

• Shah C, Wilkinson JB, Baschnagel A, Ghilezan M, Riutta J, Dekhne N, Balaraman S, Mitchell C, Wallace M, Vicini F. Factors associated with the development of breast cancer-related lymphedema after whole-breast irradiation. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1095-100. doi: 10.1016/j.ijrobp.2011.09.058. Epub 2011 Nov 16.

  PMID: 22099041 RESULT

• Ozcinar B, Guler SA, Kocaman N, Ozkan M, Gulluoglu BM, Ozmen V. Breast cancer related lymphedema in patients with different loco-regional treatments. Breast. 2012 Jun;21(3):361-5. doi: 10.1016/j.breast.2012.03.002. Epub 2012 Mar 27.

  PMID: 22460058 RESULT

• Cheville A. Prevention of lymphoedema after axillary surgery for breast cancer. BMJ. 2010 Jan 12;340:b5235. doi: 10.1136/bmj.b5235. No abstract available.

  PMID: 20068254 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 20, 2017
• Study Start: June 12, 2014
• Primary Completion: November 15, 2018
• Study Completion: December 4, 2020
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)