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NCT00542451 · OUTCOME

3-year Disease Free Survival (DFS) Rate

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer · Source last updated 2024-06-26

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

Measure
NUMBER
Unit
proportion of participant
Interval / dispersion
95% Confidence Interval
Time frame
at 3 years

What was measured

Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.

Groups in this outcome

Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer

80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab. Trastuzumab 6mg/kg over 3 weeks to complete a full year of intravenous treatment with trastuzumab.

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

Analysis denominator · Participants

GroupSource count
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer406

Reported measurements

Source class 1
Values in proportion of participant · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer0.987Not reported0.9760.998Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.976
        upper Limit
        0.998
        value
        0.987
denoms
  1. counts
    1. group Id
      OG000
      value
      406
    units
    Participants
description
Disease-free survival (DFS) is the proportion of participants ramaing disease free at 3 years based on the Kaplan-Meier method. DFS is defined to end at the time of the first of the following events: local/regional ipsilateral invasive recurrence (or ipsilateral invasive new primary), contralateral invasive breast cancer, distant recurrence, or death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    80 mg of paclitaxel per square meter of body-surface area weekly for 12 weeks and a loading dose of 4 mg of intravenous trastuzumab per kilogram of body weight on day 1, followed by 2 mg per kilogram weekly, for a total of 12 doses. After the completion of 12 weeks of treatment with Trastuzumab. Trastuzumab 6mg/kg over 3 weeks to complete a full year of intravenous treatment with trastuzumab.
    id
    OG000
    title
    Adjuvant Paclitaxel and Trastuzumab for Node-Negative HER2-Positive Breast Cancer
param Type
NUMBER
reporting Status
POSTED
time Frame
at 3 years
title
3-year Disease Free Survival (DFS) Rate
type
PRIMARY
unit Of Measure
proportion of participant

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

Preserved source evidence · Not medical advice