Clinical trial · Interventional
Axillary Reverse Mapping (ARM) Technique
A Pilot Randomized Controlled Trial Comparing the Axillary Reverse Mapping (ARM) Technique to Standard Axillary Surgery in Breast Cancer Patients.
NCT03109522CI-TRIAL-00043565ARMunknownN/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)
The purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Carcinoma in Situ of the Breast | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| axillary reverse mapping (ARM) | Procedure | — | UNRESOLVED |
| Standard axillary surgery (SLNB or ALND) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- axillary reverse mapping
- description
- Axillary reverse mapping and sentinel lymph node biopsy (ARM/SLNB) or Axillary reverse mapping and axillary lymph node dissection (ARM/ALND)
- interventionNames
- Procedure: axillary reverse mapping (ARM)
- type
- ACTIVE_COMPARATOR
- label
- standard axillary surgery
- description
- The control group will have standard sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).
- interventionNames
- Procedure: Standard axillary surgery (SLNB or ALND)
Primary outcomes (2)
- measure
- Lymphedema
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment: 1. mastectomy and sentinel lymph node biopsy 2. breast conserving surgery or mastectomy and axillary lymph node dissection 3. completion axillary lymph node dissection after positive sentinel lymph node biopsy 4. cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment - Exclusion Criteria: 1. males with breast cancer 2. women less than 18 years of age 3. known allergic reaction to patent blue dye 4. pregnant 5. previous radiation therapy to affected side 6. clinical N2/N3 disease -
References
Publications (0)
Data not yet available
No reference posted for this study.