Breast Cancer With Over-expression of erbB2-BRAINSTORM

Brief Summary

Official Title: “Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)”

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.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Retrospective
  • Study Primary Completion Date: July 2011

Interventions Used in this Clinical Trial

  • Drug: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer
    • Trastuzumab or Lapatinib

Arms, Groups and Cohorts in this Clinical Trial

  • 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).

Outcome Measures for this Clinical Trial

Primary 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
      Safety Issue?: No

Secondary 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
      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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01064349