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

  Show 74 Study Locations
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:
Neoplasm Metastasis
Breast Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014