Clinical trial · Interventional
Selective Axillary Lymph Node Dissection Vs Complete Axillary Dissection: A Randomised Clinical Trial to Assess the Prevention of Lymphedema in Breast Cancer Treatment
SELECTIVE AXILLARY LYMPH NODE DISSECTION VS COMPLETE AXILLARY DISSECTION: A RANDOMISED CLINICAL TRIAL TO ASSESS THE PREVENTION OF LYMPHEDEMA IN BREAST CANCER TREATMENT
NCT03083314CI-TRIAL-00051189completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| COMPLETE AXILLARY DISSECTION (ALND) | Procedure | — | UNRESOLVED |
| SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
- interventionNames
- Procedure: SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)
- type
- ACTIVE_COMPARATOR
- label
- COMPLETE AXILLARY DISSECTION (ALND)
- interventionNames
- Procedure: COMPLETE AXILLARY DISSECTION (ALND)
Primary outcomes (1)
- measure
- To compare the occurrence of breast-cancer-related lymphoedema (BCRL) after selective axillary dissection (SAD) and after axillary lymph node dissection (ALND)
- timeFrame
- 36 months
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (7)
- RESULTGennaro 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
- RESULTSchunemann 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
- RESULTAgresti 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
- RESULTGiuliano 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
- RESULTShah 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
- RESULTOzcinar 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.