Breast Cancer With Over-expression of erbB2-BRAINSTORM

NCT01064349 | Completed

• 1 other identifier: 113349
• Study Type: observational
• Target: 144
• Locations: 3 countries
• Sites: 10

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.

Conditions

Cancer

Keywords

ErbB2+ breast cancer; ErbB2 treatment; brain metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer DRUG

Trastuzumab or Lapatinib

Breast cancer patients with brain metastases

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.
• Brain metastasis diagnosis made between January 2006 - December 2008.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Pasay, 1300, Philippines

Location

GSK Investigational Site

Quezon City, 1101, Philippines

Location

GSK Investigational Site

Quezon City, 1102, Philippines

Location

GSK Investigational Site

Singapore, 119074, Singapore

Location

GSK Investigational Site

Bangkok, 10110, Thailand

Location

GSK Investigational Site

Bangkok, 10310, Thailand

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Bangkok, 10400, Thailand

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

Related 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.

  PMID: 22918394 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: February 8, 2010
• Study Start: May 6, 2009
• Primary Completion: June 3, 2011
• Study Completion: June 3, 2011
• Last Updated: September 14, 2018

Record last verified: 2018-05

Locations

TH (6); SG (1); PH (3)