CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 249 enrolled
Drug / intervention
Fulvestrant +1 moredrug
Likely dose
Fulvestrant 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01300351
NCT01300351Phase 3Completed
CompareCT.gov

A Randomised, Double-Blind, Parallel-Group, Multicentre Study Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Postmenopausal Women With ER+ Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy

AstraZeneca·interventional·Posted Feb 21, 2011·Updated Apr 24, 2015

In Brief

A Phase 3 clinical trial evaluating Fulvestrant and Placebo for Breast Cancer. Completed, enrolled 249 participants across 15 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 21, 2011
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 15.4 years ago

Interventions

Fulvestrantdrug

Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.

Placebodrug

Matching placebo was supplied as a castor oil based solution in clear neutral glass prefilled syringes. Each syringe will contain 5 ml.