NCT01797120 · OUTCOME

Overall Survival

Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI · Source last updated 2018-05-30

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

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Every 3 months until progression or up to 3 years

What was measured

Overall survival will be characterized using Kaplan-Meier plots and other descriptive metrics.

Analysis population: all randomized patients

Groups in this outcome

Fulvestrant & Everolimus

Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles. Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles). If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity. Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles. If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.

Fulvestrant & Placebo

Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles. Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles). If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity. Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.

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
Fulvestrant & Everolimus	66
Fulvestrant & Placebo	65

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Fulvestrant & Everolimus	28.3	Not reported	19.5	29.6	Not reported
Fulvestrant & Placebo	31.4	Not reported	21.8	NA	The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
19.5
upper Limit
29.6
value
28.3
comment
The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment
group Id
OG001
lower Limit
21.8
upper Limit
NA
value
31.4

denoms

counts
group Id
OG000
value
66
group Id
OG001
value
65
units
Participants

description

Overall survival will be characterized using Kaplan-Meier plots and other descriptive metrics.

dispersion Type

95% Confidence Interval

groups

description
Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus everolimus daily x 12 cycles. Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles). If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity. Everolimus: Everolimus 10 mg (2 tablets) daily x 12 cycles. If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity.
id
OG000
title
Fulvestrant & Everolimus
description
Fulvestrant Day 1 \& 15 of Cycle 1, then Day 1 of all subsequent cycles (every 28 days for 12 cycles) plus placebo daily x 12 cycles. Fulvestrant: Fulvestrant 500 mg Day 1 \& 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles). If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity. Placebo: Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.
id
OG001
title
Fulvestrant & Placebo

param Type

MEDIAN

population Description

all randomized patients

reporting Status

POSTED

time Frame

Every 3 months until progression or up to 3 years

title

Overall Survival

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice