NCT01077648

Brief Summary

The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

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

Study Start

First participant enrolled

February 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

3.5 years

First QC Date

February 25, 2010

Last Update Submit

May 22, 2014

Conditions

Cancer

Keywords

Breast CancerTreatmentBrain metastasesErbB2 expression

Outcome Measures

Primary Outcomes (1)

  • Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only).

    Time from breast cancer diagnosis until death or end of study periods (September 1, 2009)

Secondary Outcomes (3)

  • Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only).

    Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009)

  • Time to brain metastases stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only).

    Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis

  • Survival after brain metastases diagnosis, overall and stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only)

    Time from diagnosis of brain metastases until death or end of study period (September 1, 2009)

Study Arms (1)

Women diagnosed with advanced breast cancer

Women diagnosed with advanced breast cancer during January 1, 1995-December 31, 2007 and treated as part of the Henry Ford Health System

Drug: Trastuzumab or Lapatinib

Interventions

Trastuzumab or LapatinibDRUG

Anti-erbB2 therapy for breast cancer treatment will be analyzed as a class level variable; individual drugs including trastuzumab and lapatinib will also be explored as exposures if sufficient numbers of patients exist.

Women diagnosed with advanced breast cancer

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study aims to retrospectively collect data on nearly 4,000 advanced breast cancer cases treated within the Henry Ford Health System

You may qualify if:

  • Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
  • At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
  • Age 30 years or older at diagnosis.

You may not qualify if:

  • Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
  • Age less than 30 years or older at diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsBrain Neoplasms

Interventions

TrastuzumabLapatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 1, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 26, 2014

Record last verified: 2014-05