CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 272 enrolled
Drug / intervention
Fulvestrantdrug
Likely dose
Not stated in 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/NCT01509625
NCT01509625N/ACompleted

Assessment of Treatment Response With Faslodex® (500 mg) in Standard Clinical Practice Through a Retrospective Study

Isabel Blancas·observational·Posted Jan 13, 2012·Updated Jun 1, 2016

In Brief

An observational study evaluating Fulvestrant for Malignant Neoplasm of Breast Stage IV. Completed, enrolled 272 participants across 7 sites.

Detailed Summary

This retrospective observational study is designed to assess the response to treatment with fulvestrant at a dose of 500 mg/month with a loading dose of 500 mg (LD-500), in terms of progression free survival (PFS), overall survival (OS), and clinical benefit rate (CBR), in post-menopausal women with Advanced Breast Cancer and estrogen receptor positive, who were treated with this medicinal product and at said dose after having progressed with a previous anti-estrogen therapy. During this study, a retrospective data collection will be carried out using the information contained in the Clinical History of said patients, provided that the treatment with fulvestrant at a dose of 500 mg and LD-500.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2012
Enrollment StartJan 1, 2012
Primary CompletionJan 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.5 years ago

Interventions

Fulvestrantdrug

It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.