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NCT01622868 · ClinicalTrials.gov registry record · Phase 2
Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 143
- Enrollment target
NCT01622868: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01622868 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 143 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01622868, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 143 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Stereotactic Radiosurgery
- RADIATION Whole-Brain Radiotherapy
- DRUG Lapatinib Ditosylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2012-12-06 |
| Est. Completion | 2022-05-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01622868
The ClinicalTrials.gov registry entry for NCT01622868 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 143 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.
NCT01622868 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01622868 about?
NCT01622868 is a clinical study titled "Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer". This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spr...
What is the current status of trial NCT01622868?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2012-12-06. Estimated completion is 2022-05-20.
What interventions are being tested in trial NCT01622868?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Stereotactic Radiosurgery (RADIATION), Whole-Brain Radiotherapy (RADIATION), Lapatinib Ditosylate (DRUG).
Who is sponsoring clinical trial NCT01622868?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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