Last updated: 11/07/2018 16:22:10
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

Brain Metastases In ErbB2-Positive Breast Cancer

GSK study ID
EGF105084
See study documents
Clinicaltrials.gov ID
NCT00263588
EudraCT ID
2005-003944-68
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.

Timeframe: baseline to time of best response to treatment

Secondary outcomes:

Percentage of patients who obtain a CNS objective response or improvement in baseline NSS

Timeframe: baseline to end of treatment

Time to progression at any site

Timeframe: baseline to time of disease progression

Duration of CNS objective response

Timeframe: baseline to end of treatment

Site of first progression and cause of death

Timeframe: baseline to time of death or lost ot follow up

Percentage of patients with CNS disease control (complete response, partial response or stable disease) at 6 months of lapatinib therapy

Timeframe: baseline to end of treatment

Qualitative and quantitative toxicities associated with oral lapatinib, given at a dose of 750 mg twice a day

Timeframe: baseline to end of treatment

Relationship of PET uptake at Baseline and Week 1, as predictors of response (for those patients whose site obtained PET qualifications).

Timeframe: baseline to end of treatment

Overall survival

Timeframe: baseline to time of death or lost ot follow up

Improvement in neurological signs and symptoms (NSS), measured using the Neurological Examination Worksheet

Timeframe: baseline to end of treatment

Relationship between genetic variants in select candidate genes in the host and the efficacy and safety of lapatinib

Timeframe: baseline to end of treatment

Interventions:
  • Drug: lapatinib
    • Enrollment:
    242
    Primary completion date:
    2007-25-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Lin NU, Rubin SD, Diéras V, Paul D, Lossignol D, Christodoulou C, Stemmler HJ, Roché H, Liu M, Greil R, Ciruelos E, Loibl S, Gori S, Wardley A, Yardley D, Brufsky A, Blum J, Dharan B, Steplewski K, Zembryki D, Oliva C, Roychowdhury D, Paoletti P, Winer E . Multicenter Phase II Study of Lapatinib in Patients with Brain Metastases from HER2+ Breast Cancer . [Clin. Cancer Res.]. 2009;15(4):1452-1459.
    Medical condition
    Neoplasms, Breast
    Product
    lapatinib
    Collaborators
    Not applicable
    Study date(s)
    December 2005 to December 2016
    Type
    Interventional
    Phase
    2/3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Inclusion criteria:
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2007-25-09
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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