Breast Cancer Clinical Trial

Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

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 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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

242

Study ID:

NCT00263588

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 74 Locations for this study

See Locations Near You

Novartis Investigative Site
San Francisco California, 94115, United States
Novartis Investigative Site
Vallejo California, 94589, United States
Novartis Investigative Site
Denver Colorado, 80220, United States
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Washington District of Columbia, 20007, United States
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Boca Raton Florida, 33428, United States
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Jacksonville Florida, 32224, United States
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Indianapolis Indiana, 46202, United States
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Indianapolis Indiana, 46227, United States
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Sioux City Iowa, 51101, United States
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Kansas City Kansas, 66160, United States
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Boston Massachusetts, 02115, United States
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Ann Arbor Michigan, 48109, United States
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Minneapolis Minnesota, 55455, United States
Novartis Investigative Site
Saint Louis Missouri, 63110, United States
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Albuquerque New Mexico, 87106, United States
Novartis Investigative Site
Albuquerque New Mexico, 87108, United States
Novartis Investigative Site
Albuquerque New Mexico, 87131, United States
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Santa Fe New Mexico, 87505, United States
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New York New York, 10021, United States
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Chapel Hill North Carolina, 27599, United States
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Philadelphia Pennsylvania, 19104, United States
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Pittsburgh Pennsylvania, 15213, United States
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Nashville Tennessee, 37203, United States
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Dallas Texas, 75246, United States
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Houston Texas, 77030, United States
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Tyler Texas, 75702, United States
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Seattle Washington, 98109, United States
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Yakima Washington, 98902, United States
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North Sydney New South Wales, 2060, Australia
Novartis Investigative Site
Herston Queensland, 4029, Australia
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South Brisbane Queensland, 4101, Australia
Novartis Investigative Site
Box Hill Victoria, 3128, Australia
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Ringwood East Victoria, 3135, Australia
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Perth Western Australia, 6000, Australia
Novartis Investigative Site
Adelaide , 5000, Australia
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Salzburg , A-502, Austria
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Vienna , A-109, Austria
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Bruxelles , 1000, Belgium
Novartis Investigative Site
Vancouver British Columbia, V5Z 4, Canada
Novartis Investigative Site
Ottawa Ontario, K1H 8, Canada
Novartis Investigative Site
Toronto Ontario, M5B 1, Canada
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Toronto Ontario, M5G 2, Canada
Novartis Investigative Site
Weston Ontario, M9N 1, Canada
Novartis Investigative Site
Dijon Cedex , 21079, France
Novartis Investigative Site
Paris Cedex 05 , 75248, France
Novartis Investigative Site
Paris , 75010, France
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Toulouse cedex , 31052, France
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Muenchen Bayern, 80637, Germany
Novartis Investigative Site
Muenchen Bayern, 81377, Germany
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Frankfurt am Main Hessen, 60590, Germany
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Neo Faliro , 18547, Greece
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Bangalore , 56007, India
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Mumbai , 40002, India
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Reggio Emilia Emilia-Romagna, 42100, Italy
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Milano Lombardia, 20141, Italy
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Perugia Umbria, 06156, Italy
Novartis Investigative Site
Aichi , 464-8, Japan
Novartis Investigative Site
Saitama , 350-0, Japan
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Saitama , 350-1, Japan
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Tokyo , 104-0, Japan
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Tokyo , 113-8, Japan
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Tokyo , 135-8, Japan
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Olsztyn , 10-22, Poland
Novartis Investigative Site
Warszawa , 02-78, Poland
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Barcelona , 08035, Spain
Novartis Investigative Site
Madrid , 28041, Spain
Novartis Investigative Site
Uppsala , SE-75, Sweden
Novartis Investigative Site
Geneve , 1211, Switzerland
Novartis Investigative Site
Locarno , 6600, Switzerland
Novartis Investigative Site
Tainan County , 736, Taiwan
Novartis Investigative Site
Taipei , 10016, Taiwan
Novartis Investigative Site
Taipei , 114, Taiwan
Novartis Investigative Site
Manchester Lancashire, M20 4, United Kingdom
Novartis Investigative Site
Brighton , BN2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

242

Study ID:

NCT00263588

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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