A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Breast
Both
Neoplasms, Breast
Trial Information
A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
Inclusion Criteria
Inclusion criteria:
- Signed Informed Consent
- ErbB2(HER2)overexpressing breast cancer.
- Brain lesion(s) which are progressing.
- Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or
Stereotactic Radiosurgery (SRS).
- Prior treatment with trastuzumab (Herceptin), either alone or in combination with
chemotherapy.
- Cardiac ejection fraction(LVEF)within the institutional range of normal as measured
by Echocardiogram.
- Able to swallow an oral medication.
- Adequate kidney and liver function.
- Adequate bone marrow function.
Exclusion criteria:
- Pregnant or lactating females.
- Conditions that would effect the absorption of an oral drug.
- History of immediate or delayed hypersensitivity reaction to gadolinium contrast
agents.
- Pre-existing severe cerebral vascular disease, such as stroke involving a major
vessel.
- Serious medical or psychiatric disorder that would interfere with the patient's
safety or informed consent.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.
Outcome Time Frame:
baseline to time of best response to treatment
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
EGF105084
NCT ID:
NCT00263588
Start Date:
December 2005
Completion Date:
December 2013
Related Keywords:
- Neoplasms, Breast
- breast cancer brain metastases ErbB2 positive HER2 positive
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
- Brain Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Bakersfield, California 93309 |
| GSK Investigational Site | Gainesville, Florida 32610 |
| GSK Investigational Site | Indianapolis, Indiana 46260 |
| GSK Investigational Site | Springfield, Massachusetts 01107 |
| GSK Investigational Site | Duluth, Minnesota 55805 |
| GSK Investigational Site | St. Louis, Missouri 63141 |
| GSK Investigational Site | Albuquerque, New Mexico 87109 |
| GSK Investigational Site | Raleigh, North Carolina 27609 |
| GSK Investigational Site | Fort Worth, Texas 76104 |
| GSK Investigational Site | Bettendorf, Iowa 52722 |
| GSK Investigational Site | Royal Oak, Michigan 48073 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
| GSK Investigational Site | Germantown, Tennessee 38138 |
| GSK Investigational Site | New York, New York 10021 |
| GSK Investigational Site | Aurora, Colorado 80012 |
| GSK Investigational Site | Washington, District of Columbia 20307-5001 |
| GSK Investigational Site | Kansas City, Kansas 66160 |
| GSK Investigational Site | Seattle, Washington 98133 |
