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A Short-Term Presurgical Study to Assess the Molecular Predictors of the Antiproliferative Effects of Lapatinib (GW572016) in Primary Breast Cancer
This study is not yet open for participant recruitment.
Verified by Royal Marsden NHS Foundation Trust, January 2006
Sponsored by: Royal Marsden NHS Foundation Trust
Information provided by: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00299286
  Purpose

To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative effects of laptinib in breast cancer, ie how much lapatinib slows down the growth of cancer cells by measuring K167 (a marker of proliferation) in breast tumours before and after a short treatment with lapatinib.


Condition Intervention Phase
Breast Cancer
Drug: lapatinib
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Lapatinib Lapatinib Ditosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Further study details as provided by Royal Marsden NHS Foundation Trust:

Estimated Enrollment: 120
  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have a histological or cytologic diagnosis of primary breast cancer with a tumour size adequate for multiple core biopsie Informed signed consent Scheduled for primary surgery Expected to be compliant for duration of study Age<80 ECOG performance status 0-2 (Krnofsky >60%) Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan Eligibility of patients receiving medications known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review by the Trial Co-ordinator The effects if lapatinib on the develpoing foetus are unknown. For this reason, women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of study participation.

Able to swallow and retain oral medication.

Exclusion Criteria:

Patients with prior diagnosis of malignancy except in situ disease or basal cell carcinoma of the skin.

Patients may be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded.

Evidence of metastatic disease. Use of hormonal therapy such as oral contraceptives or hormaonal replacement therapy within 4 weeks of study entre.

Regular use of steriod hormones or other agents that could influence study endpoints History of allergic reactions attributed to compounds of similar chemical or bologic composition to GW572016.

Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00299286

Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Professor Ian Smith Royal Marsden NHS Foundation Trust
  More Information

Study ID Numbers: CCR2737
Study First Received: March 3, 2006
Last Updated: October 10, 2006
ClinicalTrials.gov Identifier: NCT00299286  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Lapatinib
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009