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Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

NCT ID: NCT00089999

Last Updated: 2017-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Neoplasms, Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lapatinib

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Hollywood, Florida, United States

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Santiago, Región Metro de Santiago, Chile

Site Status

GSK Investigational Site

Pokfulam, , Hong Kong

Site Status

GSK Investigational Site

Delhi, , India

Site Status

GSK Investigational Site

Hyderabad, Andhra Pradesh, , India

Site Status

GSK Investigational Site

Pune, , India

Site Status

GSK Investigational Site

Bandar Tun Razak, Cheras, , Malaysia

Site Status

GSK Investigational Site

Kubang Kerian, , Malaysia

Site Status

GSK Investigational Site

Tanjong Bungah, , Malaysia

Site Status

GSK Investigational Site

Tanjong Bungah, , Malaysia

Site Status

GSK Investigational Site

Ixtaltepec / Espinal, Oaxaca, Mexico

Site Status

GSK Investigational Site

Mérida, Yucatán, Mexico

Site Status

GSK Investigational Site

México, , Mexico

Site Status

GSK Investigational Site

Karachi, , Pakistan

Site Status

GSK Investigational Site

Karachi, , Pakistan

Site Status

GSK Investigational Site

Karachi, , Pakistan

Site Status

GSK Investigational Site

Lahore, , Pakistan

Site Status

GSK Investigational Site

Rawalpindi, , Pakistan

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Lima, Lima Province, Peru

Site Status

GSK Investigational Site

Callao, , Peru

Site Status

GSK Investigational Site

Bydogoszcz, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Olsztyn, , Poland

Site Status

GSK Investigational Site

Singapore, , Singapore

Site Status

GSK Investigational Site

Singapore, , Singapore

Site Status

GSK Investigational Site

Taipei, , Taiwan

Site Status

GSK Investigational Site

Taipei, , Taiwan

Site Status

Countries

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United States Chile Hong Kong India Malaysia Mexico Pakistan Peru Poland Singapore Taiwan

References

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Lipton A, Leitzel K, Ali SM, Carney W, Platek G, Steplewski K, Westlund R, Gagnon R, Martin AM, Maltzman J. Human epidermal growth factor receptor 2 (HER2) extracellular domain levels are associated with progression-free survival in patients with HER2-positive metastatic breast cancer receiving lapatinib monotherapy. Cancer. 2011 Nov 1;117(21):5013-20. doi: 10.1002/cncr.26101. Epub 2011 Mar 31.

Reference Type BACKGROUND
PMID: 21456017 (View on PubMed)

Other Identifiers

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EGF20009

Identifier Type: -

Identifier Source: org_study_id

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