Neoplasms, MetastasisBioPATHNCT01248897
Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated With Lapatinib
An observational study of Neoplasms, Metastasis, run by GlaxoSmithKline at 17 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neoplasms, Metastasis
- What is being tested?
- This study is non-interventional study, so this section is not applicable.
- How many people
- 158 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 17 Aug 2010to 5 Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asia Pacific erb2+/HER2 Breast Cancer Patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
South Korea11 sites
GSK Investigational Site
Busan, 602-030
GSK Investigational Site
Busan, 602-715
GSK Investigational Site
Busan, 602-739
GSK Investigational Site
Gangwon-do, 210-852
GSK Investigational Site
Incheon, 400-711
GSK Investigational Site
Kyunggi-do, 410-769
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 136-705
GSK Investigational Site
Seoul, 137-701
GSK Investigational Site
Songpa-gu, Seoul, 138-736
Hong Kong4 sites
GSK Investigational Site
Hong Kong
GSK Investigational Site
Pokfulam
GSK Investigational Site
Tuenmen
GSK Investigational Site
Wan Chai
About this study
Official title: A Study of Biomarker Profiles in Asia Pacific erbB2+/HER2 Breast Cancer Patients Treated With Lapatinib and Other Anti-erbB2/HER2 Therapy
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
- Being tested
- This study is non-interventional study, so this section is not applicable.
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| erbB2+/Her2 Breast Cancer Patients | erbB2+/Her2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/Her2 Therapy Receives: Other: This study is non-interventional study, so this section is not applicable. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Time from study entry to disease progression or death from any cause, in weeks
Secondary outcomes (3)
Response rate
Measured: Percentage of patients post-study entry showing complete or partial response to lapatinib
Overall survival
Measured: Time from study entry until death due to any cause, in weeks
Progression free survival
Measured: Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study start17 Aug 2010
- Primary completion1 Dec 2013
- Study completion5 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, MetastasisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248897
- Sponsor's protocol ID
- 114021
- Acronym
- BioPATH
- Status last verified
- Jun 2018
- First submitted
- 24 Nov 2010
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Biomarker Profiles in Asia Pacific erbB2+/HER2 Breast Cancer Patients Treated With Lapatinib and Other Anti-erbB2/HER2 Therapy
- ClinicalTrials.gov ID
- NCT01248897
- Acronym / sponsor ID
- BioPATH / 114021
- Conditions
- Neoplasms, Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2010
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 5 Sep 2014 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erbB2+/Her2 Breast Cancer Patients | – | Other: This study is non-interventional study, so this section is not applicable.erbB2+/Her2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/Her2 Therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asia Pacific erb2+/HER2 Breast Cancer Patients
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This study is non-interventional study, so this section is not applicable.This study is non-interventional study, so this section is not applicable. | Other | erbB2+/Her2 Breast Cancer Patients |
Primary outcome
Progression free survival
Time frame: Time from study entry to disease progression or death from any cause, in weeks
3 secondary outcomes
Response rate
Time frame: Percentage of patients post-study entry showing complete or partial response to lapatinib
Overall survival
Time frame: Time from study entry until death due to any cause, in weeks
Progression free survival
Time frame: Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Metastasis, run by GlaxoSmithKline at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in South Korea, Hong Kong, Philippines, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Time from study entry to disease progression or death from any cause, in weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.