At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
Estradioldrug
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.
A Phase II Randomized Study of Physiological (6 mg Daily) and High Dose (30 mg Daily) Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Estradiol for Breast Neoplasms. Completed, enrolled 66 participants across 7 sites.
Detailed Summary
This study aims to examine whether estradiol is an appropriate for future Phase 3 studies as second or third line endocrine treatment. In addition the protocol explores several approaches to enhance the safety of estrogen therapy, including the establishment of the efficacy of a lower dose than that currently recommended and through the early identification of non-responders to avoid drug exposure in patients who are unlikely to benefit to estrogen treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2004
First PostedMay 2006
Primary CompletionMar 2011
Study CompletionAug 2014
TodayJul 2026
First PostedMay 10, 2006
Enrollment StartAug 1, 2004
Primary CompletionMar 1, 2011
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.6 yearsPosted 20.1 years ago
Interventions
Estradioldrug