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Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00263588
Recruitment Status : Active, not recruiting
First Posted : December 9, 2005
Last Update Posted : February 21, 2018
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 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.

Condition or disease Intervention/treatment Phase
Neoplasms, Breast Drug: lapatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
Actual Study Start Date : December 2, 2005
Primary Completion Date : September 25, 2007
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: single arm
750 mg laptinib administered orally twice daily
Drug: lapatinib
tyrosine kinase inhibitor

Primary Outcome Measures :
  1. Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. [ Time Frame: baseline to time of best response to treatment ]

Secondary Outcome Measures :
  1. Improvement in neurological signs and symptoms (NSS), measured using the Neurological Examination Worksheet [ Time Frame: baseline to end of treatment ]
  2. Percentage of patients who obtain a CNS objective response or improvement in baseline NSS [ Time Frame: baseline to end of treatment ]
  3. Duration of CNS objective response [ Time Frame: baseline to end of treatment ]
  4. Percentage of patients with CNS disease control (complete response, partial response or stable disease) at 6 months of lapatinib therapy [ Time Frame: baseline to end of treatment ]
  5. Time to progression at any site [ Time Frame: baseline to time of disease progression ]
  6. Overall survival [ Time Frame: baseline to time of death or lost ot follow up ]
  7. Site of first progression and cause of death [ Time Frame: baseline to time of death or lost ot follow up ]
  8. Qualitative and quantitative toxicities associated with oral lapatinib, given at a dose of 750 mg twice a day [ Time Frame: baseline to end of treatment ]
  9. Relationship of PET uptake at Baseline and Week 1, as predictors of response (for those patients whose site obtained PET qualifications). [ Time Frame: baseline to end of treatment ]
  10. Relationship between genetic variants in select candidate genes in the host and the efficacy and safety of lapatinib [ Time Frame: baseline to end of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263588

  Hide Study Locations
United States, California
Novartis Investigative Site
San Francisco, California, United States, 94115
Novartis Investigative Site
Vallejo, California, United States, 94589
United States, Colorado
Novartis Investigative Site
Denver, Colorado, United States, 80220
United States, District of Columbia
Novartis Investigative Site
Washington, District of Columbia, United States, 20007
United States, Florida
Novartis Investigative Site
Boca Raton, Florida, United States, 33428
Novartis Investigative Site
Jacksonville, Florida, United States, 32224
United States, Indiana
Novartis Investigative Site
Indianapolis, Indiana, United States, 46202
Novartis Investigative Site
Indianapolis, Indiana, United States, 46227
United States, Iowa
Novartis Investigative Site
Sioux City, Iowa, United States, 51101-1733
United States, Kansas
Novartis Investigative Site
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Novartis Investigative Site
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Novartis Investigative Site
Saint Louis, Missouri, United States, 63110-1093
United States, New Mexico
Novartis Investigative Site
Albuquerque, New Mexico, United States, 87106
Novartis Investigative Site
Albuquerque, New Mexico, United States, 87108
Novartis Investigative Site
Albuquerque, New Mexico, United States, 87131-0001
Novartis Investigative Site
Santa Fe, New Mexico, United States, 87505
United States, New York
Novartis Investigative Site
New York, New York, United States, 10021
United States, North Carolina
Novartis Investigative Site
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Novartis Investigative Site
Philadelphia, Pennsylvania, United States, 19104
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75246
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
Tyler, Texas, United States, 75702
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98109
Novartis Investigative Site
Yakima, Washington, United States, 98902
Australia, New South Wales
Novartis Investigative Site
North Sydney, New South Wales, Australia, 2060
Australia, Queensland
Novartis Investigative Site
Herston, Queensland, Australia, 4029
Novartis Investigative Site
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Novartis Investigative Site
Box Hill, Victoria, Australia, 3128
Novartis Investigative Site
Ringwood East, Victoria, Australia, 3135
Australia, Western Australia
Novartis Investigative Site
Perth, Western Australia, Australia, 6000
Novartis Investigative Site
Adelaide, Australia, 5000
Novartis Investigative Site
Salzburg, Austria, A-5020
Novartis Investigative Site
Vienna, Austria, A-1090
Novartis Investigative Site
Bruxelles, Belgium, 1000
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Novartis Investigative Site
Toronto, Ontario, Canada, M5B 1W8
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site
Weston, Ontario, Canada, M9N 1N8
Novartis Investigative Site
Dijon Cedex, France, 21079
Novartis Investigative Site
Paris Cedex 05, France, 75248
Novartis Investigative Site
Paris, France, 75010
Novartis Investigative Site
Toulouse cedex, France, 31052
Novartis Investigative Site
Muenchen, Bayern, Germany, 80637
Novartis Investigative Site
Muenchen, Bayern, Germany, 81377
Novartis Investigative Site
Frankfurt am Main, Hessen, Germany, 60590
Novartis Investigative Site
Neo Faliro, Greece, 18547
Novartis Investigative Site
Bangalore, India, 560078
Novartis Investigative Site
Mumbai, India, 400026
Novartis Investigative Site
Reggio Emilia, Emilia-Romagna, Italy, 42100
Novartis Investigative Site
Milano, Lombardia, Italy, 20141
Novartis Investigative Site
Perugia, Umbria, Italy, 06156
Novartis Investigative Site
Aichi, Japan, 464-8681
Novartis Investigative Site
Saitama, Japan, 350-0495
Novartis Investigative Site
Saitama, Japan, 350-1298
Novartis Investigative Site
Tokyo, Japan, 104-0045
Novartis Investigative Site
Tokyo, Japan, 113-8677
Novartis Investigative Site
Tokyo, Japan, 135-8550
Novartis Investigative Site
Olsztyn, Poland, 10-228
Novartis Investigative Site
Warszawa, Poland, 02-781
Novartis Investigative Site
Barcelona, Spain, 08035
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Uppsala, Sweden, SE-751 85
Novartis Investigative Site
Geneve, Switzerland, 1211
Novartis Investigative Site
Locarno, Switzerland, 6600
Novartis Investigative Site
Tainan County, Taiwan, 736
Novartis Investigative Site
Taipei, Taiwan, 10016
Novartis Investigative Site
Taipei, Taiwan, 114
United Kingdom
Novartis Investigative Site
Manchester, Lancashire, United Kingdom, M20 4BX
Novartis Investigative Site
Brighton, United Kingdom, BN2 5BE
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00263588     History of Changes
Other Study ID Numbers: EGF105084
First Posted: December 9, 2005    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
breast cancer brain metastases ErbB2 positive HER2 positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action