Clinical trial NCT01064349: Breast Cancer With Over-expression of erbB2-BRAINSTORM
Official title: Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: ErbB2+ breast cancer
ErbB2 treatment
brain metastases
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 144
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study aims to enrol approximately 300 Erb2+ breast cancer cases with brain metastases in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand).

Brief summary: This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.


Eligibility criteria: Inclusion Criteria:

1. Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
2. Brain metastasis diagnosis made between January 2006 - December 2008.

Exclusion Criteria:

1. Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
2. Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)

Primary outcomes:
measure: To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.
timeFrame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
Secondary outcomes:
measure: To describe the survival of ErbB2 over-expressing breast cancer patients with brain metastasis after diagnosis of brain metastasis in relation to the receipt of anti-erbB2 therapy.
timeFrame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
measure: Describe association between usage of anti-erbB2 therapy (before brain metastasis) & 1) time interval from diagnosis of erbB2+ breast cancer to occurrence of brain metastasis and 2) occurrence of brain metastasis as the first site of disease progression
timeFrame: Time (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis
Other outcomes:
Locations:
city: Pasay City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Yap YS, Cornelio GH, Devi BC, Khorprasert C, Kim SB, Kim TY, Lee SC, Park YH, Sohn JH, Sutandyo N, Wong DW, Kobayashi M, Landis SH, Yeoh EM, Moon H, Ro J. Brain metastases in Asian HER2-positive breast cancer patients: anti-HER2 treatments and their impact on survival. Br J Cancer. 2012 Sep 25;107(7):1075-82. doi: 10.1038/bjc.2012.346. Epub 2012 Aug 23.