Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Completed · Phase 2

Conditions studied: Neoplasms, Breast

In brief

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 treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

Key facts

Study ID

NCT00263588

Run by

Novartis Pharmaceuticals

People needed

242

Starts

2005-12-02

Expected to finish

2018-03-15

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Vallejo, California, United States
• Novartis Investigative Site — Denver, Colorado, United States
• Novartis Investigative Site — Washington D.C., District of Columbia, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Sioux City, Iowa, United States
• Novartis Investigative Site — Kansas City, Kansas, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Albuquerque, New Mexico, United States
• Novartis Investigative Site — Albuquerque, New Mexico, United States
• Novartis Investigative Site — Albuquerque, New Mexico, United States
• Novartis Investigative Site — Santa Fe, New Mexico, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Francisco, California, United States

Full record on ClinicalTrials.gov

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