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Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

NCT ID: NCT00263588

Last Updated: 2019-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-02

Study Completion Date

2018-03-15

Brief Summary

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Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

Detailed Description

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Conditions

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Neoplasms, Breast

Keywords

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breast cancer brain metastases ErbB2 positive HER2 positive neoplasms cancer lapatinib LAP016A2202 LAP016A CLAP016A2202 GW572016

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

750 mg lapatinib administered orally twice daily

Group Type EXPERIMENTAL

lapatinib

Intervention Type DRUG

tyrosine kinase inhibitor

Interventions

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lapatinib

tyrosine kinase inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed Informed Consent
* ErbB2(HER2)overexpressing breast cancer.
* Brain lesion(s) which are progressing.
* Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or Stereotactic Radiosurgery (SRS).
* Prior treatment with trastuzumab (Herceptin), either alone or in combination with chemotherapy.
* Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by Echocardiogram.
* Able to swallow an oral medication.
* Adequate kidney and liver function.
* Adequate bone marrow function.

Exclusion Criteria

* Pregnant or lactating females.
* Conditions that would effect the absorption of an oral drug.
* History of immediate or delayed hypersensitivity reaction to gadolinium contrast agents.
* Pre-existing severe cerebral vascular disease, such as stroke involving a major vessel.
* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

San Francisco, California, United States

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Vallejo, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Jacksonville, Florida, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Sioux City, Iowa, United States

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Kansas City, Kansas, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Santa Fe, New Mexico, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Tyler, Texas, United States

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Seattle, Washington, United States

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Yakima, Washington, United States

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North Sydney, New South Wales, Australia

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Herston, Queensland, Australia

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South Brisbane, Queensland, Australia

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Box Hill, Victoria, Australia

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Ringwood East, Victoria, Australia

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Perth, Western Australia, Australia

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Adelaide, , Australia

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Salzburg, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Weston, Ontario, Canada

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Dijon, , France

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Paris, , France

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Paris, , France

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Toulouse, , France

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Neo Faliro, , Greece

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Bangalore, , India

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Mumbai, , India

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Reggio Emilia, Emilia-Romagna, Italy

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Milan, Lombardy, Italy

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Perugia, Umbria, Italy

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Aichi, , Japan

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Saitama, , Japan

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Saitama, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Olsztyn, , Poland

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Warsaw, , Poland

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Barcelona, , Spain

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Madrid, , Spain

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Uppsala, , Sweden

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Geneva, , Switzerland

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Locarno, , Switzerland

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Tainan County, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Manchester, Lancashire, United Kingdom

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Brighton, , United Kingdom

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Countries

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United States Australia Austria Belgium Canada France Germany Greece India Italy Japan Poland Spain Sweden Switzerland Taiwan United Kingdom

References

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Sutherland S, Ashley S, Miles D, Chan S, Wardley A, Davidson N, Bhatti R, Shehata M, Nouras H, Camburn T, Johnston SR. Treatment of HER2-positive metastatic breast cancer with lapatinib and capecitabine in the lapatinib expanded access programme, including efficacy in brain metastases--the UK experience. Br J Cancer. 2010 Mar 16;102(6):995-1002. doi: 10.1038/sj.bjc.6605586. Epub 2010 Feb 23.

Reference Type RESULT
PMID: 20179708 (View on PubMed)

Other Identifiers

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CLAP016A2202

Identifier Type: OTHER

Identifier Source: secondary_id

2005-003944-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EGF105084

Identifier Type: -

Identifier Source: org_study_id