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NCT00863655 · OUTCOME

Proportion of Patients With Having no Overall Response Based on Investigator Assessment

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
NUMBER
Unit
Proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
2, 4, 6, 9 months

What was measured

overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. 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: All randomized patients were included in the Full Analysis Set.

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 + Exemestane485
Placebo + Exemestane239

Reported measurements

2 months
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane0.96Not reported0.940.98Not reported
Placebo + Exemestane1.00Not reported0.971.00Not reported
4 months
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane0.93Not reported0.910.95Not reported
Placebo + Exemestane1.00Not reported0.971.00Not reported
6 months
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane0.92Not reported0.890.94Not reported
Placebo + Exemestane1.00Not reported0.971.00Not reported
9 months
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane0.90Not reported0.880.93Not reported
Placebo + Exemestane1.00Not reported0.971.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.94
        upper Limit
        0.98
        value
        0.96
      2. group Id
        OG001
        lower Limit
        0.97
        upper Limit
        1.00
        value
        1.00
    title
    2 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.91
        upper Limit
        0.95
        value
        0.93
      2. group Id
        OG001
        lower Limit
        0.97
        upper Limit
        1.00
        value
        1.00
    title
    4 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.89
        upper Limit
        0.94
        value
        0.92
      2. group Id
        OG001
        lower Limit
        0.97
        upper Limit
        1.00
        value
        1.00
    title
    6 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.88
        upper Limit
        0.93
        value
        0.90
      2. group Id
        OG001
        lower Limit
        0.97
        upper Limit
        1.00
        value
        1.00
    title
    9 months
denoms
  1. counts
    1. group Id
      OG000
      value
      485
    2. group Id
      OG001
      value
      239
    units
    Participants
description
overall response = complete response (CR) + partial response (PR) per RECIST 1.0 Time to overall response (CR or PR) based on investigator is the time between date of randomization/start of treatment until first documented response (CR or PR). This analysis included all patients/responders. Patients who did not achieve a confirmed PR or CR were censored at last adequate tumor assessment date when they did not progress. 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
NUMBER
population Description
All randomized patients were included in the Full Analysis Set.
reporting Status
POSTED
time Frame
2, 4, 6, 9 months
title
Proportion of Patients With Having no Overall Response Based on Investigator Assessment
type
SECONDARY
unit Of Measure
Proportion of patients

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

Preserved source evidence · Not medical advice