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NCT00390455 · ClinicalTrials.gov registry record · Phase 3
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 295
- Enrollment target
NCT00390455: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00390455 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 295 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00390455, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 295 participants
- Enrollment target
Study Summary
This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.
Primary Outcome
PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Fulvestrant
- OTHER Placebo Administration
- DRUG Lapatinib Ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 295 participants |
| Start Date | 2006-09-15 |
| Est. Completion | 2014-07-02 |
| Phase | Phase 3 |
What the finished NCT00390455 record still lists
NCT00390455 is an interventional study that assigns participants to a tested intervention. The registered 295 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00390455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00390455 about?
NCT00390455 is a clinical study titled "Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive". This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone...
What is the current status of trial NCT00390455?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 295 participants. The study started on 2006-09-15. Estimated completion is 2014-07-02.
What interventions are being tested in trial NCT00390455?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Fulvestrant (DRUG), Placebo Administration (OTHER), Lapatinib Ditosylate (DRUG).
Who is sponsoring clinical trial NCT00390455?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00390455's enrollment target sits among peer trials
295 1166th of 2000 higher than 835 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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