Sentinel Node Biopsy and Axillary Sampling in Operable Breast Cancer

This study has been terminated.
(After initiation of study many studies reported an equivalence of SNB and ALND which led to widespread adoption of the former as standard procedure.)
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Rajendra A. Badwe, Tata Memorial Centre
ClinicalTrials.gov Identifier:
NCT00128362
First received: August 8, 2005
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Cancer of the Breast
Procedure: Radio-guided sentinel node biopsy
Procedure: Axillary sampling
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Trial of Sentinel Node Biopsy Versus Axillary Sampling in Women With Clinically Node Negative Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Comparison of methodologies in predicting status of axillary lymph nodes [ Time Frame: Within 30 days after surgery ] [ Designated as safety issue: No ]
    The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.


Secondary Outcome Measures:
  • Number of lymph nodes identified by sentinel node biopsy and axillary sampling [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: No ]
    The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.

  • Number of times the sentinel node is found within the sampled nodes [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: No ]
    The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.

  • False negative rate by each method [ Time Frame: within 30 days of surgery ] [ Designated as safety issue: No ]
    The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.

  • Negative predictive value for each method [ Time Frame: within 30 days of surgery ] [ Designated as safety issue: No ]
    The patient enrolled on this study will be planned for surgery and outcome will be measured after avability of histo-pathological report.


Enrollment: 478
Study Start Date: September 2005
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radio guided Sentinle node biopsy
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 biopsy Procedure: Axillary sampling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Palpable axillary lymph nodes
  • Contraindications for injecting radiocolloid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128362

Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400 012
Sponsors and Collaborators
Tata Memorial Hospital
Indian Council of Medical Research
Investigators
Principal Investigator: Rajendra A Badwe, M.S. Tata Memorial Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rajendra A. Badwe, Director, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT00128362     History of Changes
Other Study ID Numbers: TMH/115/2003, No.5/13/66/2003-NCD-III
Study First Received: August 8, 2005
Last Updated: June 23, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Tata Memorial Hospital:
Sentinel node
Axillary sampling
Operable breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014