GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

20 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  Lapatinib 1500mg QD

Study Details

This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.

Key Dates

Start date

Nov 28, 2005

Status verified

Aug 2018

Primary completion

Apr 1, 2009

Completion

Apr 1, 2009

Study Design

Enrollment

62 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinb
  Lapatinib 1500mg QD

Primary Outcome Measure

Overall Tumor Response [ Time Frame: Baseline and then followed every 4 weeks until disease progression or death. If treatment was terminated due to adverse events, then followed every 12 weeks until disease progression is noted. ]