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NCT00903162 · ClinicalTrials.gov registry record · Phase 2
Extended Endocrine Therapy for Premenopausal Women With Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00903162 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 17 participants.
The verdict
NCT00903162, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA approved. It has been shown to reduce the risk of breast cancer recurrence in postmenopausal women with breast cancer who have been previously treated with tamoxifen. Letrozole works by stopping the production of estrogen in parts of the body other than the ovaries. Leuprolide is a drug that stops a women's ovarian cycles. This process is known as ovarian function suppression. Stopping a women's menstrual cycle may be effective against breast cancer for some patients when given as initial therapy. The combination of letrozole and leuprolide is considered a standard treatment for women with metastatic breast cancer, and is also sometimes used for treatment of premenopausal early stage breast cancer, but it has not been accepted as a standard of care treatment.
Interventions
- DRUG letrozole
- DRUG zoledronic acid
- DRUG leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-05 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00903162
The ClinicalTrials.gov registry entry for NCT00903162 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which letrozole is the first listed.
NCT00903162 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00903162 about?
NCT00903162 is a clinical study titled "Extended Endocrine Therapy for Premenopausal Women With Breast Cancer". The purpose of this study is to determine the safety and tolerability of the combination of two drugs (letrozole and leuprolide) in women who have already taken tamoxifen for at least 4.5 years. Letrozole, an aromatase inhibitor (which blocks an enzyme that produces estrogen), is a drug that is FDA ...
What is the current status of trial NCT00903162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2009-05. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00903162?
The interventions under investigation include: letrozole (DRUG), zoledronic acid (DRUG), leuprolide (DRUG).
Who is sponsoring clinical trial NCT00903162?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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