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NCT00863655 · OUTCOME

Overall Response Rate (ORR)

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

Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) 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.

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 + Exemestane9.5Not reportedNot reportedNot reportedNot reported
Placebo + Exemestane0.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9.5
      2. group Id
        OG001
        value
        0.4
denoms
  1. counts
    1. group Id
      OG000
      value
      485
    2. group Id
      OG001
      value
      239
    units
    Participants
description
Overall response rate (ORR) is the percentage of patients with a best overall response of complete response (CR) or partial response (PR) 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.
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
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice