Clinical trial · Interventional
Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma
Randomized Clinical Trial Comparing Axillary Dissection "by Principle" and Axillary Dissection Based on the Histological Result of the Sentinel Node, in Patients With Breast Carcinoma of Small Size
- 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 study is to evaluate the disease free and overall survival of patients with breast carcinomas of small size, i.e., not greater than 2.0 cm and with clinically non palpable axillary lymph nodes, undergoing either conservative surgery and axillary dissection, or a similar treatment for the primary tumor and rapid analysis of the sentinel lymph node, the result of which determines axillary node dissection or its avoidance is based.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| quadrantectomy and axillary dissection | Procedure | — | UNRESOLVED |
| quadrantectomy + sentinel node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- QUART
- description
- Patients in this arm will receive quadrantectomy, axillary dissection and radiotherapy (the current standard therapy).
- interventionNames
- Procedure: quadrantectomy and axillary dissection
- type
- EXPERIMENTAL
- label
- QURT (SN-)
- description
- Patients will receive quadrantectomy, sentinel node investigation and radiotherapy. Selective axillary dissection will be performed if sentinel node is positive.
- interventionNames
- Procedure: quadrantectomy + sentinel node biopsy
Primary outcomes (1)
- measure
- disease free survival, overall survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 40 and 75 years. * Clinical, mammographic or ultrasonographic diagnosis of a unicentric carcinoma with an ultrasonographic diameter of equal or less than 2.0 cm. * Although not a factor of exclusion, a breast scintigraphy using MDP-99m is recommended for accurate determination of possible multifocality or multicentricity of the tumor, as well as for the determination of possible bone metastasis. * Axillary lymph nodes that cannot be palpated or that are not clinically suspicious for metastasis. * No previously executed therapy (including biopsy) at any outside institution. * Those patients with nonpalpable lesions will be subjected to preoperative radioactive occult lesion localization (ROLL) or stereotactic biopsy. * Adequate patient information and signature of the informed consent. Exclusion Criteria: * Lesions diagnosed as non-infiltrating (in-situ) ductal or lobular carcinoma. * Paget's disease. * Documented multicentricity and/or abundant multifocality of the neoplasm. * Clinically metastatic lymph nodes. * Patients previously biopsied at other institutions. * Carcinomas detected during pregnancy or lactation. * Histotypes diverse from breast carcinoma lesions. * History of previous malignancy (excluding basocellular carcinoma, in-situ cervical carcinoma and/or contralateral breast carcinoma without recurrence for at least 15 years of follow-up).
References
Publications (1)
- DERIVEDVeronesi U, Viale G, Paganelli G, Zurrida S, Luini A, Galimberti V, Veronesi P, Intra M, Maisonneuve P, Zucca F, Gatti G, Mazzarol G, De Cicco C, Vezzoli D. Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study. Ann Surg. 2010 Apr;251(4):595-600. doi: 10.1097/SLA.0b013e3181c0e92a. PMID 20195151