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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00390455
The ClinicalTrials.gov registry entry for NCT00390455 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 295 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00390455 reports 0 study locations.
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.
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