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NCT00324259 · ClinicalTrials.gov registry record · Phase 2
Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT00324259: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT00324259 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00324259, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study 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.
Primary Outcome
Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0 CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease SD is defined as lack of disease progression by 24 weeks.
Interventions
- DRUG Estradiol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2004-08 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT00324259 record still lists
NCT00324259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Estradiol is the first listed.
NCT00324259 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00324259 about?
NCT00324259 is a clinical study titled "Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer". 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...
What is the current status of trial NCT00324259?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2004-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00324259?
The interventions under investigation include: Estradiol (DRUG).
Who is sponsoring clinical trial NCT00324259?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00324259's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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