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NCT00863655 · OUTCOME

Clinical Benefit Rate (CBR)

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
Percentage of participants
Interval / dispersion
Not reported
Time frame
up to 21 months

What was measured

CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) \>= 24 weeks, according to RECIST 1.0. 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.

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

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus + Exemestane33.4Not reportedNot reportedNot reportedNot reported
Placebo + Exemestane18.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33.4
      2. group Id
        OG001
        value
        18.0
denoms
  1. counts
    1. group Id
      OG000
      value
      485
    2. group Id
      OG001
      value
      239
    units
    Participants
description
CBR is defined as the percentage of patients with best overall response of either complete response (CR), a partial response (PR) or stable disease (SD) \>= 24 weeks, according to RECIST 1.0. 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; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline.
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
up to 21 months
title
Clinical Benefit Rate (CBR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice