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NCT00411788 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00411788 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 11 participants.
The verdict
NCT00411788, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of breast cancer. This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin on breast cancer. Rapamune and Herceptin are being combined because results from our laboratory studies suggest that the combination of the two drugs is superior to either drug used alone. Results from laboratory studies performed at other institutions suggest that adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there has been extensive experience using Herceptin alone and Rapamune alone in human subjects, the combination of Herceptin and Rapamune has not been previously evaluated. In addition, we hope to better understand how these treatments work against an individual woman's tumor by analyzing tissue samples before, and during treatment.
Interventions
- DRUG Trastuzumab
- DRUG Rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00411788
The ClinicalTrials.gov registry entry for NCT00411788 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trastuzumab is the first listed.
NCT00411788 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00411788 about?
NCT00411788 is a clinical study titled "A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer". Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not ...
What is the current status of trial NCT00411788?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2006-12. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00411788?
The interventions under investigation include: Trastuzumab (DRUG), Rapamycin (DRUG).
Who is sponsoring clinical trial NCT00411788?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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