NCT00062686

Brief Summary

This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_2

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

June 11, 2003

Last Update Submit

April 14, 2015

Conditions

Neoplasms, Breast

Keywords

LapatinibMetastatic Breast CancerHERCEPTIN refractory

Outcome Measures

Primary Outcomes (1)

  • Tumor response rate

Secondary Outcomes (1)

  • clinical benefit rate time to progression 4 and 6 month progression free survival overall survival

Interventions

GW572016DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent.
  • Histologically confirmed Stage IIIb or IV breast cancer.
  • Refractory breast cancer defined as progression in the metastatic setting after prior therapy with anthracyclines, taxanes and capecitibine.
  • Subjects with documented ErbB2 tumor overexpression must have received at least 6 cycles of trastuzumab.
  • Documented disease progression of the most recent treatment is required.
  • Archived tumor tissue available for testing.
  • Measurable lesions according to Response Evaluation Criteria In Solid Tumors (RECIST).
  • At least 3 weeks since prior cancer therapies except for trastuzumab which must be discontinued at least 2 weeks prior to the beginning of study drug.
  • Bisphosphonate therapy initiated prior to study entry is allowed, however, initiation of bisphosphonates following study entry is not allowed.
  • Able to swallow and retain oral medication.
  • Cardiac ejection fraction within the institutional normal range as measured by echocardiogram or MUGA (Multiple Gated Acquisition) scan.
  • Adequate kidney and liver function.
  • Adequate bone marrow function.

You may not qualify if:

  • Pregnant or lactating.
  • Copies of nadir scans and/or photographs of the tumor prior to disease progression as well as scans documenting disease progression are not available for review.
  • Malabsorption syndrome, ulcerative colitis, disease significantly affecting gastrointestinal function or resection of the stomach or small bowel.
  • History of other malignancy.
  • Serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent.
  • Active or uncontrolled infection.
  • Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
  • Known history of or clinical evidence of leptomeningeal carcinomatosis.
  • Active infection.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or IV steroids.
  • Unresolved or unstable serious toxicity from prior therapy.
  • Prior treatment with an ErbB1 and/or ERbB2 inhibitor other than trastuzumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Buenos Aires, Buenos Aires, C1455BWU, Argentina

Location

GSK Investigational Site

Villejuif, 94805, France

Location

GSK Investigational Site

Augsburg, Bavaria, 86150, Germany

Location

GSK Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

GSK Investigational Site

Bebington, Wirral, CH63 4JY, United Kingdom

Location

GSK Investigational Site

London, SW3 6JJ, United Kingdom

Location

GSK Investigational Site

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2003

First Posted

June 12, 2003

Study Start

November 1, 2003

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

AR(1)GB(4)DE(1)FR(1)