Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: August 18, 2004
Last updated: March 10, 2011
Last verified: March 2011

August 18, 2004
March 10, 2011
June 2004
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To evaluate the clinical response of oral GW572016 at 12 weeks [ Time Frame: 12 Weeks ]
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Complete list of historical versions of study NCT00089999 on Archive Site
duration of response,safety, biomarker [ Time Frame: 12 Weeks ]
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Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
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

This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

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Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma Breast Stage IV
  • Neoplasms, Breast
Drug: Lapatinib
Other Name: Lapatinib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   Hong Kong,   India,   Malaysia,   Mexico,   Pakistan,   Peru,   Singapore,   Taiwan
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP