Breast Cancer With Over-expression of erbB2-BRAINSTORM

Cancer Clinical Trial

Official title:

Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064349
• Other study ID #: 113349
• Status: Completed
• Start date: May 6, 2009
• Est. completion date: June 3, 2011

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: June 3, 2011
• Est. primary completion date: June 3, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer

Intervention

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

Locations

Country	Name	City	State
Philippines	GSK Investigational Site	Pasay City
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Quezon City
Singapore	GSK Investigational Site	Singapore
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiangmai

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Philippines,  Singapore,  Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.		Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
Secondary	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 (in months) from date of first diagnosis of brain metastasis through to death or end of study period
Secondary	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 (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis