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

February 25, 2010
May 22, 2014
February 2010
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01077648 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Brain Metastasis in Breast Cancer Patients
Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease

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.

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
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

Cancer
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.
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
Intervention: Drug: Trastuzumab or Lapatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Female
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01077648
112951
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP