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

NCT01248897 | Completed

• 1 other identifier: 114021
• Study Type: observational
• Target: 158
• Locations: 4 countries
• Sites: 17

Brief 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.

Conditions

Neoplasms, Metastasis

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Time from study entry to disease progression or death from any cause, in weeks

Secondary Outcomes (3)

• Response rate

  Percentage of patients post-study entry showing complete or partial response to lapatinib

• Overall survival

  Time from study entry until death due to any cause, in weeks

• Progression free survival

  Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks

Study Arms (1)

erbB2+/Her2 Breast Cancer Patients

erbB2+/Her2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/Her2 Therapy

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

Interventions

This study is non-interventional study, so this section is not applicable. OTHER

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

erbB2+/Her2 Breast Cancer Patients

Eligibility Criteria

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

Study Population

Asia Pacific erb2+/HER2 Breast Cancer Patients

You may qualify if:

• 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.
• 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.
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (17)

GSK Investigational Site

Hong Kong, Hong Kong

Location

GSK Investigational Site

Pokfulam, Hong Kong

Location

GSK Investigational Site

Tuenmen, Hong Kong

Location

GSK Investigational Site

Wan Chai, Hong Kong

Location

GSK Investigational Site

Pasay, 1300, Philippines

Location

GSK Investigational Site

Singapore, 169610, Singapore

Location

GSK Investigational Site

Busan, 602-030, South Korea

Location

GSK Investigational Site

Busan, 602-715, South Korea

Location

GSK Investigational Site

Busan, 602-739, South Korea

Location

GSK Investigational Site

Gangwon-do, 210-852, South Korea

Location

GSK Investigational Site

Incheon, 400-711, South Korea

Location

GSK Investigational Site

Kyunggi-do, 410-769, South Korea

Location

GSK Investigational Site

Seoul, 110-744, South Korea

Location

GSK Investigational Site

Seoul, 120-752, South Korea

Location

GSK Investigational Site

Seoul, 136-705, South Korea

Location

GSK Investigational Site

Seoul, 137-701, South Korea

Location

GSK Investigational Site

Songpa-gu, Seoul, 138-736, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissues

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: August 17, 2010
• Primary Completion: December 1, 2013
• Study Completion: September 5, 2014
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

KR (11); PH (1); SG (1); HK (4)