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Breast Cancer With Over-expression of erbB2-BRAINSTORM

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01064349
First received: January 21, 2010
Last updated: September 1, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Cancer
Breast Cancer
 Drug: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries. [ Time Frame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Time (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer patients with brain metastases
Female Erb2+ breast cancer patients with brain metastases diagnosed between January 2006 and December 2008 in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand).
 Drug: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer
Trastuzumab or Lapatinib

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064349

Locations
Philippines
GSK Investigational Site
Pasay City, Philippines, 1300
GSK Investigational Site
Quezon City, Philippines, 1102
GSK Investigational Site
Quezon City, Philippines, 1101
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
Thailand
GSK Investigational Site
Bangkok, Thailand, 10110
GSK Investigational Site
Bangkok, Thailand, 10330
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Bangkok, Thailand, 10310
GSK Investigational Site
Bangkok, Thailand, 10700
GSK Investigational Site
Chiangmai, Thailand, 50200
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01064349     History of Changes
Other Study ID Numbers: 113349
Study First Received: January 21, 2010
Last Updated: September 1, 2011
Health Authority: United Kingdom: GSK Observational Study

Keywords provided by GlaxoSmithKline:
ErbB2+ breast cancer
ErbB2 treatment
brain metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013