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NCT00611715 · ClinicalTrials.gov registry record · Phase 2
Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00611715 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 48 participants.
The verdict
NCT00611715, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.
Interventions
- OTHER laboratory biomarker analysis
- DRUG letrozole
- OTHER immunohistochemistry staining method
- DRUG erlotinib hydrochloride
- GENETIC fluorescence in situ hybridization
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2003-11 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00611715
The ClinicalTrials.gov registry entry for NCT00611715 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00611715 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00611715 about?
NCT00611715 is a clinical study titled "Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.". RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together ...
What is the current status of trial NCT00611715?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2003-11. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00611715?
The interventions under investigation include: laboratory biomarker analysis (OTHER), letrozole (DRUG), immunohistochemistry staining method (OTHER), erlotinib hydrochloride (DRUG), fluorescence in situ hybridization (GENETIC).
Who is sponsoring clinical trial NCT00611715?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
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