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NCT00099437 · OUTCOME

Clinical Benefit Rate (CBR)

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
Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

What was measured

A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) \>=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.

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 mg374
Fulvestrant 500 mg362

Reported measurements

Source class 1
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fulvestrant 250 mg39.6Not reportedNot reportedNot reportedNot reported
Fulvestrant 500 mg45.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        39.6
      2. group Id
        OG001
        value
        45.6
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      362
    units
    Participants
description
A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) \>=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.
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
reporting Status
POSTED
time Frame
Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)
title
Clinical Benefit Rate (CBR)
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice