Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib

Neoplasms, Metastasis Clinical Trial

— BioPATH  

Official title:

A Study of Biomarker Profiles in Asia Pacific erbB2+/HER2 Breast Cancer Patients Treated With Lapatinib and Other Anti-erbB2/HER2 Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248897
• Other study ID #: 114021
• Status: Completed
• Start date: August 17, 2010
• Est. completion date: September 5, 2014

Study information

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

Clinical Trial Summary

The purpose of this study is to understand how information of 3 specific biomarkers can provide guidance to physicians in the treatment of erbB2 positive breast cancer patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 5, 2014
• Est. primary completion date: December 1, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. HER2-positive (defined as either (a) IHC3+ or (b) FISH+ in local lab) recurrent / metastatic breast cancer patients who have received treatment with lapatinib-based regimen. These are either new, current or completed cases from any of the following settings:

• treated according to physician's clinical judgement in routine practice; or

• treated in clinical trials with known allocation to lapatinib-based regimen; or

• treated via lapatinib expanded access or named patient programs. These regimens should contain lapatinib as the only anti-HER2 agent.

2. Exposed to < 2 lines of trastuzumab-based regimen in the metastatic setting prior to start of lapatinib-based regimen. These regimens should contain trastuzumab as the only anti-HER2 agent.

3. Patients with an historical tumor biopsy specimen available from their primary breast cancer diagnosis. If this is not available, then at least a specimen should be available anytime during the period before the patient started on any anti-HER2 therapy.

4. Willing to give written informed consent to release the tumor biopsy specimen with corresponding clinical data. If consent could be waived according to institutional practice (eg. patient already deceased, or patient previously provided blanket consent for institution to utilize tissue/data for research purpose), this is accepted with appropriate supporting documentation.

Exclusion Criteria:

1. Patients who have been exposed to other experimental anti-HER2 therapy eg. pertuzumab, trastuzumab-DM, neratinib, ertumaxomab, AV-412, BIBW2992, CUDC-101, anti-HER2 vaccines.

2. Other primary lesions that are not of breast origin.

Related Conditions & MeSH terms

• Neoplasms, Metastasis

Intervention

Other:
• This study is non-interventional study, so this section is not applicable.
This study is non-interventional study, so this section is not applicable.

Locations

Country	Name	City	State
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Tuen Mun
Hong Kong	GSK Investigational Site	Wanchai
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Gangwon-do
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Kyunggi-do
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Songpa-gu, Seoul
Philippines	GSK Investigational Site	Pasay City
Singapore	GSK Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Philippines,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Time from study entry to disease progression or death from any cause, in weeks
Secondary	Response rate		Percentage of patients post-study entry showing complete or partial response to lapatinib
Secondary	Overall survival		Time from study entry until death due to any cause, in weeks
Secondary	Progression free survival		Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks