Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00263588
First received: December 2, 2005
Last updated: August 7, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Neoplasms, Breast
Drug: lapatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer. [ Time Frame: baseline to time of best response to treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in neurological signs and symptoms (NSS), measured using the Neurological Examination Worksheet [ Time Frame: baseline to end of treatment ] [ Designated as safety issue: No ]
  • Percentage of patients who obtain a CNS objective response or improvement in baseline NSS [ Time Frame: baseline to end of treatment ] [ Designated as safety issue: No ]
  • Duration of CNS objective response [ Time Frame: baseline to end of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to progression at any site [ Time Frame: baseline to time of disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: baseline to time of death or lost ot follow up ] [ Designated as safety issue: No ]
  • Site of first progression and cause of death [ Time Frame: baseline to time of death or lost ot follow up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: December 2005
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm
750 mg laptinib administered orally twice daily
Drug: lapatinib
tyrosine kinase inhibitor
Other Name: lapatinib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263588

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

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00263588     History of Changes
Other Study ID Numbers: EGF105084
Study First Received: December 2, 2005
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
breast cancer brain metastases ErbB2 positive HER2 positive

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

ClinicalTrials.gov processed this record on October 21, 2014