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 GSK Clinical Study Register is no longer maintained for this study.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
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
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
Observational study model:
Not applicable
Primary completion date:
2007-25-09
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
- Signed Informed Consent
- ErbB2(HER2)overexpressing breast cancer.
- Pregnant or lactating females.
- Conditions that would effect the absorption of an oral drug.
Inclusion and exclusion 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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
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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