Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089999
First received: August 18, 2004
Last updated: March 10, 2011
Last verified: March 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 June 18, 2013