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NCT00570258 · ClinicalTrials.gov registry record · Phase 2
Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy
A Phase 2 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT00570258: Clinical Trial Phase 2 study, sponsored by University of Arkansas.
NCT00570258 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00570258, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy. 1. To obtain preliminary estimates of the magnitude and variability of the efficacy of fulvestrant in combination with erlotinib in this subject population, and 2. To obtain historically up-to-date estimates of the magnitude and variability of the efficacy of fulvestrant as the sole active agent in this subject population. The measure of efficacy for both primary objectives will be time to progression.
Primary Outcome
This will be defined as the date from randomization onset to first documented occurrence of PD. Death will be regarded as a progression event in those subjects who die before disease progression. Subjects without documented objective progression at the time of the final analysis will be censored at the date of their last tumor assessment.
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2006-09 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
Why NCT00570258 stopped before completion
NCT00570258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00570258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00570258 about?
NCT00570258 is a clinical study titled "Randomized, Double Blind Multicenter Phase II Study of Time to Progression on Fulvestrant in Combination With Erlotinib or Placebo in Hormone Receptor-Positive Metastatic Breast Cancer (MBC) Subjects Who Progressed on First Line Hormonal Therapy". This is a multicenter, randomized, double-blind study of fulvestrant plus erlotinib versus fulvestrant plus placebo for subjects with metastatic breast cancer whose disease progression after first line hormonal therapy. 1. To obtain preliminary estimates of the magnitude and variability of the effi...
What is the current status of trial NCT00570258?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2006-09. Estimated completion is 2017-12.
What interventions are being tested in trial NCT00570258?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), erlotinib (DRUG).
Who is sponsoring clinical trial NCT00570258?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00570258's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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