Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00863655 · OUTCOME

Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole · Source last updated 2017-05-02

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
21 months

What was measured

Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

Analysis population: Randomized patients with best overall response of CR or PR.

Groups in this outcome

Everolimus + Exemestane

Everolimus 10 mg daily in combination with exemestane 25 mg daily

Placebo + Exemestane

Placebo of everolimus in combination with exemestane 25 mg daily

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

Analysis denominator · Participants

GroupSource count
Everolimus + Exemestane46
Placebo + Exemestane1

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane8.21Not reported5.55NANA - upper limit was not estimable
Placebo + ExemestaneNANot reportedNANANA - median, lower and upper limit of the 95 % CI were not estimable
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA - upper limit was not estimable
        group Id
        OG000
        lower Limit
        5.55
        upper Limit
        NA
        value
        8.21
      2. comment
        NA - median, lower and upper limit of the 95 % CI were not estimable
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Duration of response of CR or PR based on investigator applies only to patients whose best overall response was CR or PR (RECIST 1.0). The start date was the date of first documented response (CR or PR) and the end date and censoring is defined the same as that for time to progression. Per RECIST criteria 1.0, CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
dispersion Type
95% Confidence Interval
groups
  1. description
    Everolimus 10 mg daily in combination with exemestane 25 mg daily
    id
    OG000
    title
    Everolimus + Exemestane
  2. description
    Placebo of everolimus in combination with exemestane 25 mg daily
    id
    OG001
    title
    Placebo + Exemestane
param Type
MEDIAN
population Description
Randomized patients with best overall response of CR or PR.
reporting Status
POSTED
time Frame
21 months
title
Duration of Response (Among Participants With Best Overall Response of CR or PR) Estimated Per Kaplan-Meier
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice