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A Phase II, Open-Label, Randomized, Parallel-Group Multicenter Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients With Advanced or Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Carcinoma Breast Stage IV, Neoplasms, Breast

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Trial Information

A Phase II, Open-Label, Randomized, Parallel-Group Multicenter Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients With Advanced or Metastatic Breast Cancer

Inclusion Criteria


Inclusion criteria:

- Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with
T4 lesion or stage IV disease at primary diagnosis or at relapse after curative
intent surgery.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

- Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)

- Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)

- Adequate renal, hepatic and cardiac function

Exclusion criteria:

- Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other
than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including
trastuzumab) will be allowed provided it was stopped at least 12 months before study
entry.

- Patients with active brain metastases

- Patients with bilateral breast cancer, bone metastases as the only disease site or
metastases to more than 30% of the hepatic parenchyma.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the clinical response of oral GW572016 at 12 weeks

Outcome Time Frame:

12 Weeks

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF20009

NCT ID:

NCT00089999

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Carcinoma Breast Stage IV
  • Neoplasms, Breast
  • lapatinib
  • advanced
  • metastatic breast cancer
  • GW572016
  • ErbB2
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma

Name

Location

GSK Investigational SiteGainesville, Florida  32610