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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 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 27 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00570258
The ClinicalTrials.gov registry entry for NCT00570258 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00570258 reports 0 study locations.
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.
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