Last updated: 11/03/2018 16:02:10
Study of Biomarker Profiles in Asia Pacific erb2+/HER2 Breast Cancer Patients Treated with LapatinibBioPATH
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Study of Biomarker Profiles in Asia Pacific erbB2+/HER2 Breast Cancer Patients Treated with Lapatinib and Other Anti-erbB2/HER2 Therapy
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Progression free survival
Timeframe: Time from study entry to disease progression or death from any cause, in weeks
Secondary outcomes:
Response rate
Timeframe: Percentage of patients post-study entry showing complete or partial response to lapatinib
Overall survival
Timeframe: Time from study entry until death due to any cause, in weeks
Progression free survival
Timeframe: Time from first initiation of any trastuzumab-based treatment to disease progression or death from any cause, in weeks
Interventions:
Other: This study is non-interventional study, so this section is not applicable.
Enrollment:
158
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Neoplasms, Metastasis
Product
lapatinib
Collaborators
Not applicable
Study date(s)
August 2010 to September 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
No
- 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
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
songpa-gu, Seoul, South Korea, 138-736
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2014-05-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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