NCT00021255 · OUTCOME

Overall Survival- Percentage of Participants Who Survived at 10 Years

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer · Source last updated 2016-11-15

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

Measure: NUMBER
Unit: percentage of particpants
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization until death or up to 10 years

What was measured

Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.

Analysis population: ITT population.

Groups in this outcome

Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)

Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.

AC Followed by Docetaxel + Herceptin (AC→TH)

Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.

Docetaxel + Carboplatin + Herceptin (TCH)

Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.

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
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)	1073
AC Followed by Docetaxel + Herceptin (AC→TH)	1074
Docetaxel + Carboplatin + Herceptin (TCH)	1075

Reported measurements

Source class 1

Values in percentage of particpants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)	78.9	Not reported	76.2	81.5	Not reported
AC Followed by Docetaxel + Herceptin (AC→TH)	86.0	Not reported	83.8	88.2	Not reported
Docetaxel + Carboplatin + Herceptin (TCH)	83.4	Not reported	81.0	85.8	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
76.2
upper Limit
81.5
value
78.9
group Id
OG001
lower Limit
83.8
upper Limit
88.2
value
86.0
group Id
OG002
lower Limit
81.0
upper Limit
85.8
value
83.4

denoms

counts
group Id
OG000
value
1073
group Id
OG001
value
1074
group Id
OG002
value
1075
units
Participants

description

Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.

dispersion Type

95% Confidence Interval

groups

description
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
id
OG000
title
Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)
description
Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
id
OG001
title
AC Followed by Docetaxel + Herceptin (AC→TH)
description
Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
id
OG002
title
Docetaxel + Carboplatin + Herceptin (TCH)

param Type

NUMBER

population Description

ITT population.

reporting Status

POSTED

time Frame

From randomization until death or up to 10 years

title

Overall Survival- Percentage of Participants Who Survived at 10 Years

type

SECONDARY

unit Of Measure

percentage of particpants

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

Preserved source evidence · Not medical advice