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NCT00099437 · OUTCOME

Duration of Clinical Benefit (DoCB)

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
MEDIAN
Unit
Time (in months)
Interval / dispersion
Full Range
Time frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

What was measured

Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) \>=24 weeks

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 mg148
Fulvestrant 500 mg165

Reported measurements

Source class 1
Values in Time (in months) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Fulvestrant 250 mg13.9Not reported3.7NANot Applicable - not all participants had an event at time of analysis, max time censored
Fulvestrant 500 mg16.6Not reported2.5NANot Applicable - not all participants had an event at time of analysis, max time censored
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not Applicable - not all participants had an event at time of analysis, max time censored
        group Id
        OG000
        lower Limit
        3.7
        upper Limit
        NA
        value
        13.9
      2. comment
        Not Applicable - not all participants had an event at time of analysis, max time censored
        group Id
        OG001
        lower Limit
        2.5
        upper Limit
        NA
        value
        16.6
denoms
  1. counts
    1. group Id
      OG000
      value
      148
    2. group Id
      OG001
      value
      165
    units
    Participants
description
Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) \>=24 weeks
dispersion Type
Full Range
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
MEDIAN
reporting Status
POSTED
time Frame
RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
title
Duration of Clinical Benefit (DoCB)
type
SECONDARY
unit Of Measure
Time (in months)

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

Preserved source evidence · Not medical advice