Brain Metastasis in Breast Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01077648
First received: February 25, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Cancer
Drug: Trastuzumab or Lapatinib

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Proportion of advanced stage breast cancer patients that develop brain metastases, overall and stratified by anti-HER2 therapy (for HER2+ patients only). [ Time Frame: Time from breast cancer diagnosis until death or end of study periods (September 1, 2009) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival from advanced stage breast cancer, overall and stratified by tumor characteristics and anti-HER2 therapy (for HER2+ patients only). [ Time Frame: Time from diagnosis of advanced stage breast cancer until death or end of study period (September 1, 2009) ] [ Designated as safety issue: No ]
  • Time to brain metastases stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only). [ Time Frame: Time from diagnosis of advanced stage breast cancer until brain metastases diagnosis ] [ Designated as safety issue: No ]
  • Survival after brain metastases diagnosis, overall and stratified by key tumor characteristics and anti-HER2 therapy (for HER2+ patients only) [ Time Frame: Time from diagnosis of brain metastases until death or end of study period (September 1, 2009) ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

Detailed Description:

A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.

Other secondary outcomes to be explored include:

  • Survival after advanced breast cancer—time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
  • Time to brain metastases—time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
  • Survival after brain metastases—time in months from the date of diagnosis of brain metastases until death or end of study period
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077648

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01077648     History of Changes
Other Study ID Numbers: 112951
Study First Received: February 25, 2010
Last Updated: May 22, 2014
Health Authority: United Kingdom: GSK Observational Study

Keywords provided by GlaxoSmithKline:
Breast Cancer
Treatment
Brain metastases
ErbB2 expression

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trastuzumab
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014