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NCT00499681 · ClinicalTrials.gov registry record · Phase 2
PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE
A Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00499681: Clinical Trial Phase 2 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT00499681 is a Phase 2 study that was terminated before completion, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00499681, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt-Ingram Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast cancer that can be removed by surgery.
Primary Outcome
Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
Interventions
- OTHER placebo
- DRUG letrozole
- DRUG lapatinib ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-07 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
Why NCT00499681 stopped before completion
NCT00499681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00499681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00499681 about?
NCT00499681 is a clinical study titled "PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE". RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together w...
What is the current status of trial NCT00499681?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-07. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00499681?
The interventions under investigation include: placebo (OTHER), letrozole (DRUG), lapatinib ditosylate (DRUG).
Who is sponsoring clinical trial NCT00499681?
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 NCT00499681's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 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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