Clinical trial · Interventional
Sentinel Node Biopsy and Axillary Sampling in Operable Breast Cancer
Clinical Trial of Sentinel Node Biopsy Versus Axillary Sampling in Women With Clinically Node Negative Operable Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After initiation of study many studies reported an equivalence of SNB and ALND which led to widespread adoption of the former as standard procedure.
Summary
Brief summary (as posted)
The advent of mammography and increased awareness of breast cancer has resulted in detection of smaller tumors, the majority of which would not have had metastasized to the axillary lymph nodes. The sentinel node (SN) is presumably the first echelon node in the axillary basin to become involved with metastatic breast cancer cells. Sentinel node biopsy (SNB) in operable breast cancer has gained popularity since it promises to avoid treatment of the axilla when the nodes are negative for metastasis. Advances in technology (radio-guided SNB) is associated with a risk of false negative SN reporting in 4-12%. The consequence of leaving behind untreated positive non-sentinel nodes in the axilla is a potential risk for axillary recurrence. Axillary sampling is a simple and inexpensive procedure in which level I nodes are removed by a blind dissection. The investigators critically analyzed the efficacy of both the procedures separately in consecutive pilot studies i.e., targeted SNB versus blind axillary sampling. The current study is planned as a prospective comparison study where a patient undergoes both the procedures in the same surgical intervention and thus provides an immediate comparison of the two techniques with respect to their effectiveness.
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 |
|---|---|---|---|
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary sampling | Procedure | — | UNRESOLVED |
| Radio-guided sentinel node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radio guided Sentinle node biopsy
- description
- The radiolabeled Tc-99 colloid or phytate (500 Mbq) will be injected into the primary tumor 2 hours before surgery. A localized scintiscan will then be performed to confirm the radiolabeling of the sentinel node before surgery and for documentation. Isosulphan blue dye will be injected subdermal (0.5ml) over the tumor and intraparenchymal (3-4ml) towards the axilla 10-15mins before incision.
- interventionNames
- Procedure: Radio-guided sentinel node biopsy
- Procedure: Axillary sampling
Primary outcomes (1)
- measure
- Comparison of methodologies in predicting status of axillary lymph nodes
- timeFrame
- Within 30 days after surgery
- description
- The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Clinically node negative operable breast cancer * No prior incision or excision biopsy Exclusion Criteria: * Palpable axillary lymph nodes * Contraindications for injecting radiocolloid
References
Publications (2)
- BACKGROUNDBadwe RA, Thorat MA, Parmar VV. Sentinel-node biopsy in breast cancer. N Engl J Med. 2003 Nov 13;349(20):1968-71; author reply 1968-71. doi: 10.1056/NEJM200311133492017. No abstract available. PMID 14614174
- DERIVEDParmar V, Hawaldar R, Nair NS, Shet T, Vanmali V, Desai S, Gupta S, Rangrajan V, Mittra I, Badwe RA. Sentinel node biopsy versus low axillary sampling in women with clinically node negative operable breast cancer. Breast. 2013 Dec;22(6):1081-6. doi: 10.1016/j.breast.2013.06.006. Epub 2013 Aug 13. PMID 23948301