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NCT00099437 · OUTCOME

Objective Response Rate (ORR)

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. · Source last updated 2026-06-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
Not reported
Time frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

What was measured

Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.

Analysis population: All patients with measurable disease at baseline.

Groups in this outcome

Fulvestrant 250 mg

Fulvestrant 250 mg Intramuscular Injection every 28 days

Fulvestrant 500 mg

Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14

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 250 mg261
Fulvestrant 500 mg240

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fulvestrant 250 mg14.6Not reportedNot reportedNot reportedNot reported
Fulvestrant 500 mg13.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14.6
      2. group Id
        OG001
        value
        13.8
denoms
  1. counts
    1. group Id
      OG000
      value
      261
    2. group Id
      OG001
      value
      240
    units
    Participants
description
Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.
groups
  1. description
    Fulvestrant 250 mg Intramuscular Injection every 28 days
    id
    OG000
    title
    Fulvestrant 250 mg
  2. description
    Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
    id
    OG001
    title
    Fulvestrant 500 mg
param Type
NUMBER
population Description
All patients with measurable disease at baseline.
reporting Status
POSTED
time Frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice