Clinical trial · Interventional
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node
NCT00072293CI-TRIAL-0003133123-01completedN/AResults postedClinicalTrials.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)
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.
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 |
|---|---|---|---|
| Axillary lymph node dissection | Procedure | — | UNRESOLVED |
| No axillary lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Axillary Dissection
- description
- Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
- interventionNames
- Procedure: Axillary lymph node dissection
- type
- EXPERIMENTAL
- label
- No Axillary Dissection
- description
- Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
- interventionNames
- Procedure: No axillary lymph node dissection
Primary outcomes (1)
- measure
- 5-year Disease-Free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
* Largest tumor lesion ≤ 5 cm
* Palpable or nonpalpable breast lesion
* Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions
* Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
* At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension
* No clinical evidence of distant metastases
* No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following:
* Skeletal pain of unknown cause
* Elevated alkaline phosphatase
* Bone scan showing hot spots
* No palpable axillary lymph node(s)
* No Paget's disease without invasive cancer
* Hormone receptor status:
* Estrogen receptor and progesterone receptor known
PATIENT CHARACTERISTICS:
Age
* Any age
Sex
* Female
Menopausal status
* Any status
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* See Disease Characteristics
Renal
* Not specified
Other
* Not pregnant or nursing
* No other prior or concurrent malignancy except the following:
* Adequately treated basal cell or squamous cell skin cancer
* Adequately treated carcinoma in situ of the cervix
* Adequately treated in situ melanoma
* Contralateral or ipsilateral carcinoma in situ of the breast
* No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
* Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
Other
* No prior systemic therapy for breast cancer
* More than 1 year since prior chemopreventive agentReferences
Publications (2)
- DERIVEDGalimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5. PMID 30196031
- DERIVEDGalimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11. PMID 23491275