NCT00128362

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

6.3 years

First QC Date

August 8, 2005

Last Update Submit

June 23, 2014

Conditions

Cancer of the Breast

Keywords

Sentinel nodeAxillary samplingOperable breast cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of methodologies in predicting status of axillary lymph nodes

    The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.

    Within 30 days after surgery

Secondary Outcomes (4)

  • Number of lymph nodes identified by sentinel node biopsy and axillary sampling

    Within 30 days of surgery

  • Number of times the sentinel node is found within the sampled nodes

    Within 30 days of surgery

  • False negative rate by each method

    within 30 days of surgery

  • Negative predictive value for each method

    within 30 days of surgery

Study Arms (1)

Radio guided Sentinle node biopsy

EXPERIMENTAL

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.

Procedure: Radio-guided sentinel node biopsyProcedure: Axillary sampling

Interventions

Radio-guided sentinel node biopsyPROCEDURE
Radio guided Sentinle node biopsy
Axillary samplingPROCEDURE
Radio guided Sentinle node biopsy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically node negative operable breast cancer
  • No prior incision or excision biopsy

You may not qualify if:

  • Palpable axillary lymph nodes
  • Contraindications for injecting radiocolloid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400 012, India

Location

Related Publications (2)

  • Badwe 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: 14614174BACKGROUND

  • Parmar 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: 23948301DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rajendra A Badwe, M.S.

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2011

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

IN(1)