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NCT00458237 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
A Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT00458237: Completed Phase 1 study, sponsored by Beth Israel Deaconess Medical Center.
NCT00458237 is a Phase 1 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00458237, a Phase 1 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid arthritis, in recipients of solid-organ transplants, healthy volunteers and experiments with animals, and information from those other research studies suggest that this RAD001 may help to stop cancer cells from growing abnormally.
Primary Outcome
The MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. Dose Limiting Toxicities (DLTs) were defined as follows (CTCAE v4.0): * Any grade 4 hematologic toxicity, excluding anemia. * Any grade 3 or 4 nonhematologic toxicity, except for nausea, vomiting, diarrhea, or hyperlipidemia that responds promptly (within
Interventions
- DRUG Trastuzumab
- DRUG Everolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2007-04 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT00458237 record still lists
NCT00458237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT00458237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00458237 about?
NCT00458237 is a clinical study titled "Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer". The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab. RAD001 has been used in patients with severe rheumatoid arthritis, in recipients o...
What is the current status of trial NCT00458237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2007-04. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00458237?
The interventions under investigation include: Trastuzumab (DRUG), Everolimus (DRUG).
Who is sponsoring clinical trial NCT00458237?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00458237's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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