Breast Cancer With Over-expression of erbB2-BRAINSTORM

Completed

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

• Registration Number: NCT01064349
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-06
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-08
• Primary Completion: 2011-06-03
• Study Completion: 2011-06-03
• Status Verified: 2018-05
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients with brain metastases	Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇹🇭 Chiangmai, Thailand