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Sentinel Node Biopsy and Axillary Sampling in Operable Breast Cancer

NCT00128362 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2014-06-24

No results posted yet for this study

Summary

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

  • Cancer of the Breast

Interventions

PROCEDURE

Radio-guided sentinel node biopsy

PROCEDURE

Axillary sampling

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Tata Memorial Hospital

    lead OTHER_GOV

Principal Investigators

  • Rajendra A Badwe, M.S. · Tata Memorial Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2011-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00128362 on ClinicalTrials.gov