Status:
COMPLETED
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neoplasms, Breast
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 2 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2018
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00263588
Start Date
December 2 2005
End Date
March 15 2018
Last Update
December 12 2019
Active Locations (74)
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1
Novartis Investigative Site
San Francisco, California, United States, 94115
2
Novartis Investigative Site
Vallejo, California, United States, 94589
3
Novartis Investigative Site
Denver, Colorado, United States, 80220
4
Novartis Investigative Site
Washington D.C., District of Columbia, United States, 20007