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A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Breast

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Trial Information

A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.

Outcome Time Frame:

baseline to time of best response to treatment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF105084

NCT ID:

NCT00263588

Start Date:

December 2005

Completion Date:

December 2013

Related Keywords:

  • Neoplasms, Breast
  • breast cancer brain metastases ErbB2 positive HER2 positive
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Brain Neoplasms

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteAlbuquerque, New Mexico  87109
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteBettendorf, Iowa  52722
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteSeattle, Washington  98133