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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Trastuzumab or Lapatinib

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

• Study Type: Observational
• Enrollment (Actual): 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): March 1, 2010

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 22, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Treatment; Breast Cancer; Brain metastases; ErbB2 expression
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Trastuzumab; Lapatinib
• Other Study ID Numbers: 112951