Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089999
First received: August 18, 2004
Last updated: March 10, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Carcinoma Breast Stage IV
Neoplasms, Breast
Drug: Lapatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the clinical response of oral GW572016 at 12 weeks [ Time Frame: 12 Weeks ]

Secondary Outcome Measures:
  • duration of response,safety, biomarker [ Time Frame: 12 Weeks ]

Enrollment: 130
Study Start Date: June 2004
Intervention Details:
    Drug: Lapatinib
    Other Name: Lapatinib
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089999

Locations
United States, Florida
GSK Investigational Site
Hollywood, Florida, United States, 33021
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8380456
Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
India
GSK Investigational Site
Delhi, India, 110085
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
GSK Investigational Site
Pune, India, 411001
Malaysia
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 59100
GSK Investigational Site
Kubang Kerian, Malaysia, 16150
GSK Investigational Site
Tanjong Bungah, Malaysia, 10450
GSK Investigational Site
Tanjong Bungah, Malaysia, 11200
Mexico
GSK Investigational Site
Ixtaltepec / Espinal, Oaxaca, Mexico, 70140
GSK Investigational Site
Merida, Yucatán, Mexico, 97500
Pakistan
GSK Investigational Site
Karachi, Pakistan
GSK Investigational Site
Karachi, Pakistan, 54000
GSK Investigational Site
Karachi, Pakistan, 74800
GSK Investigational Site
Rawalpindi, Pakistan
Peru
GSK Investigational Site
Callao, Peru, Callao 2
GSK Investigational Site
Lima, Peru, Lima 11
GSK Investigational Site
Lima, Peru, Lima 34
GSK Investigational Site
Lima, Peru, Lima 13
Singapore
GSK Investigational Site
Singapore, Singapore, 169610
GSK Investigational Site
Singapore, Singapore, 258500
Taiwan
GSK Investigational Site
Taipei, Taiwan, 114
GSK Investigational Site
Taipei, Taiwan, 100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00089999     History of Changes
Other Study ID Numbers: EGF20009
Study First Received: August 18, 2004
Last Updated: March 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
lapatinib
advanced
metastatic breast cancer
GW572016
ErbB2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Carcinoma
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lapatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014