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NCT01797120 · OUTCOME

Objective Response Rate

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
NUMBER
Unit
proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
Every 3 months until progression or up to 3 years

What was measured

Objective response rate is defined as number of patients with complete or partial response (by Physical Exam, CT or MRI) divided by number of patients randomized in each arm

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

GroupSource count
Fulvestrant & Everolimus66
Fulvestrant & Placebo65

Reported measurements

Source class 1
Values in proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fulvestrant & Everolimus0.182Not reported0.0980.296Not reported
Fulvestrant & Placebo0.123Not reported0.0550.228Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.47
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.47
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.098
        upper Limit
        0.296
        value
        0.182
      2. group Id
        OG001
        lower Limit
        0.055
        upper Limit
        0.228
        value
        0.123
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    2. group Id
      OG001
      value
      65
    units
    Participants
description
Objective response rate is defined as number of patients with complete or partial response (by Physical Exam, CT or MRI) divided by number of patients randomized in each arm
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
NUMBER
population Description
all randomized patients
reporting Status
POSTED
time Frame
Every 3 months until progression or up to 3 years
title
Objective Response Rate
type
SECONDARY
unit Of Measure
proportion of patients

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

Preserved source evidence · Not medical advice