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NCT00138125 · ClinicalTrials.gov registry record · Phase 2
Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer
A Phase 2 study, sponsored by Translational Oncology Research International.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00138125: Clinical Trial Phase 2 study, sponsored by Translational Oncology Research International.
NCT00138125 is a Phase 2 study that was terminated before completion, run by Translational Oncology Research International. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00138125, a Phase 2 study, was terminated before completion, sponsored by Translational Oncology Research International.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.
Primary Outcome
Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.
Interventions
- BIOLOGICAL Herceptin
- DRUG Faslodex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2005-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
Why NCT00138125 stopped before completion
NCT00138125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Herceptin is the first listed.
NCT00138125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00138125 about?
NCT00138125 is a clinical study titled "Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer". RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to...
What is the current status of trial NCT00138125?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2005-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00138125?
The interventions under investigation include: Herceptin (BIOLOGICAL), Faslodex (DRUG).
Who is sponsoring clinical trial NCT00138125?
This trial is sponsored by Translational Oncology Research International, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00138125's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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