Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Nervous System Diseases

Neoplasm Metastasis

Breast Neoplasms

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trastuzumab

Lapatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

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.

Trastuzumab or Lapatinib

GSK Clinical Trials

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

Brain Metastasis in Breast Cancer Patients

Occurrence of Brain Metastasis in Breast Cancer Patients Diagnosed at Advanced Stages of the Disease

GlaxoSmithKline

Breast Diseases

Skin Diseases

Day1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks

Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally

Filippo Montemurro, MD

Manuela Muliello, Study Coordinator

Massimo Aglietta, Full Professor, MD

This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological study will assess factors correlated with sensitivity or resistance to either one of the compounds

Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

A Phase II, Randomized Trial With Single Agent Trastuzumab or Lapatinib in Patients With Metastatic HER2-Overexpressing Breast Cancer

Azienda Ospedaliera Ordine Mauriziano di Torino

Prof. Massimo Aglietta / Dr Filippo Montemurro

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Brain Metastasis in Breast Cancer Patients	NCT01077648	Cancer	Trastuzumab or ...	30 Years -	GlaxoSmithKline
Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer	NCT00842998	Metastatic Brea...	Trastuzumab or ...	18 Years - 75 Years	Azienda Ospedaliera Ordine Mauriziano di Torino

Spots Global Cancer Trial Database for trastuzumab or lapatinib