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A Double Blind Short-Term Presurgical Study Assessing the Molecular Antiproliferative Predictors of Lapatinib's Effects in Breast Cancer

Phase 2
18 Years
80 Years
Not Enrolling
Breast Cancer

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Trial Information

A Double Blind Short-Term Presurgical Study Assessing the Molecular Antiproliferative Predictors of Lapatinib's Effects in Breast Cancer

Randomised multi centre double blind pre-surgical study in women with a histological
diagnosis of breast cancer by core biopsy.

Inclusion Criteria:

Patients must have a histological or cytologic diagnosis of primary breast cancer with a
tumour size adequate for multiple core biopsies Informed signed consent Scheduled for
primary surgery Expected to be compliant for duration of study Age<80 ECOG performance
status 0-2 (Karnofsky >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 Coordinator
The effects if lapatinib on the developing fetus 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
hormonal replacement therapy within 4 weeks of study entry.

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Changes in Ki67 after short term treatment with lapatinib.

Outcome Description:

Paired core samples taken at baseline and time of main surgery analysed for Ki67, TUNEL, HER2, EGFR, ER, PgR, pAkt,pERK & stathmin

Outcome Time Frame:

11-14 days after treatment

Safety Issue:


Principal Investigator

Professor Ian Smith

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Marsden NHS Foundation Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2007

Completion Date:

August 2011

Related Keywords:

  • Breast Cancer
  • Ki67
  • Molecular
  • antiproliferative
  • Breast Neoplasms