NCT01772472 · OUTCOME

Overall Survival (OS) Rate at 5 Years

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: At Year 5

What was measured

OS was defined as the time from randomization to death due to any cause. 5-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 5 years after randomization was estimated.

Analysis population: ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.

Groups in this outcome

Trastuzumab

Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

Trastuzumab Emtansine

Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

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
Trastuzumab	743
Trastuzumab Emtansine	743

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Trastuzumab	87.71	Not reported	85.20	90.22	Not reported
Trastuzumab Emtansine	91.40	Not reported	89.30	93.50	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.91
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0082
param Type
Hazard Ratio (HR)
param Value
0.70
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.53
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.91
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0082
param Type
Hazard Ratio (HR)
param Value
0.70
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
85.20
upper Limit
90.22
value
87.71
group Id
OG001
lower Limit
89.30
upper Limit
93.50
value
91.40

denoms

counts
group Id
OG000
value
743
group Id
OG001
value
743
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
OG000
title
Trastuzumab
description
Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
id
OG001
title
Trastuzumab Emtansine

param Type

NUMBER

population Description

ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.

reporting Status

POSTED

time Frame

At Year 5

title

Overall Survival (OS) Rate at 5 Years

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice