Brain Metastasis in Breast Cancer Patients
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 1 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 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 |
This study aims to retrospectively collect data on nearly 4,000 advanced breast cancer cases treated within the Henry Ford Health System
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 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 9, 2013 |
| 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 May 23, 2013