Clinical trial
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With…
NCT00390455 · National Cancer Institute (NCI), NIH · Completed
Key facts
| NCT number | NCT00390455 |
|---|---|
| Title | Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive |
| Official title | Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer |
| Lead sponsor | National Cancer Institute (NCI), NIH |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Estrogen Receptor Positive, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7 |
| Intervention type | Drug, Other |
| Interventions | Fulvestrant, Laboratory Biomarker Analysis, Lapatinib Ditosylate, Placebo Administration |
| Enrollment | 295 |
| Start date | Sep 15, 2006 |
| Primary completion | Jul 1, 2014 |
| Completion | Jul 2, 2014 |
| First posted | Oct 19, 2006 |
| Last update posted | Dec 20, 2019 |
| Countries | United States |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: