At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 156 enrolled
Drug / intervention
AMG 479 +1 moredrug
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.
An International, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of AMG 479 With Exemestane or Fulvestrant in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating AMG 479 and Placebo for Breast Cancer and 2 related conditions. Completed, enrolled 156 participants across 60 sites in 9 countries.
Detailed Summary
This is a randomized, double-blind, placebo-controlled, phase 2 study. Subjects will include postmenopausal women with confirmed HR-positive, locally advanced or metastatic breast cancer, who have disease progression during or within 12 months after completing prior adjuvant endocrine therapy or during the first prior endocrine therapy for metastatic disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Tumors, Metastatic Cancer
CountriesAustralia, Canada, France, Germany, Ireland, Spain, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartMar 2008
Primary CompletionMay 2010
Study CompletionSep 2011
TodayJul 2026
First PostedFeb 29, 2008
Enrollment StartMar 27, 2008
Primary CompletionMay 5, 2010
Study CompletionSep 23, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.3 years ago
Interventions
AMG 479drug
AMG 479 administered with exemestane or fulvestrant
Placebodrug
Placebo administered with either exemestane or fulvestrant