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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: Clinical Trial Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00611715 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
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 |
Why NCT00611715 stopped before completion
NCT00611715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.
NCT00611715 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00611715's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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