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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
COMPLETE AXILLARY DISSECTION (ALND)
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Massimiliano Gennaro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)

COMPLETE AXILLARY DISSECTION (ALND)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 2, 2017
Last Updated
April 8, 2021
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT03083314
Brief Title
Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2014 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
December 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
Arm Type
Experimental
Arm Title
COMPLETE AXILLARY DISSECTION (ALND)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
Intervention Type
Procedure
Intervention Name(s)
COMPLETE AXILLARY DISSECTION (ALND)
Primary Outcome Measure Information:
Title
To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND)
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
To compare costs in the axillary lymph node dissection (ALND) and selective axillary dissection (SAD) arms
Description
To compare costs in the ALND and SAD arms including: lymphoscintigraphy, time required for surgery, and treatments required for lymphedema during follow up.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Massimiliano Gennaro
City
Milan
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24113621
Citation
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.
Results Reference
result
PubMed Identifier
24599413
Citation
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.
Results Reference
result
PubMed Identifier
24323615
Citation
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.
Results Reference
result
PubMed Identifier
21304082
Citation
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.
Results Reference
result
PubMed Identifier
22099041
Citation
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.
Results Reference
result
PubMed Identifier
22460058
Citation
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.
Results Reference
result
PubMed Identifier
20068254
Citation
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.
Results Reference
result

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

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