NCT00003830 · OUTCOME

Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.

Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer · Source last updated 2017-12-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: At time of surgery (within 30 days of randomization)

What was measured

Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.

Analysis population: Data not collected for some patients. This analysis as pre-specified in the approved B-32 protocol required that both a SLN resection and an ALND be performed. The patients in Arm II were assigned to have no ALND so were excluded from the analysis.

Groups in this outcome

Arm I:Sentinel Node Resection+Conventional Axillary Dissection

Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.

Arm II: Sentinel Node Resection Followed by Node Examination

Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Arm I:Sentinel Node Resection+Conventional Axillary Dissection	766
Arm II: Sentinel Node Resection Followed by Node Examination	0

Reported measurements

Source class 1

False Negative

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I:Sentinel Node Resection+Conventional Axillary Dissection	75	Not reported	Not reported	Not reported	Not reported

True Negative

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I:Sentinel Node Resection+Conventional Axillary Dissection	691	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
75
title
False Negative
measurements
group Id
OG000
value
691
title
True Negative

denoms

counts
group Id
OG000
value
766
group Id
OG001
value
0
units
Participants

description

groups

description
Sentinel node resection immediately followed by axillary dissection conventional surgery: Sentinel node resection immediately followed by axillary dissection.
id
OG000
title
Arm I:Sentinel Node Resection+Conventional Axillary Dissection
description
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. Sentinel node resection followed by node examination: Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
id
OG001
title
Arm II: Sentinel Node Resection Followed by Node Examination

param Type

COUNT_OF_PARTICIPANTS

population Description

Data not collected for some patients. This analysis as pre-specified in the approved B-32 protocol required that both a SLN resection and an ALND be performed. The patients in Arm II were assigned to have no ALND so were excluded from the analysis.

reporting Status

POSTED

time Frame

At time of surgery (within 30 days of randomization)

title

Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice