Neoplasms, BreastNCT01476111
Evaluation of Specific Biomarkers in Primary Invasive Breast Cancer
An observational study of Neoplasms, Breast, run by GlaxoSmithKline at 29 sites in 6 countries.
Trial summary
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Breast
- How many people
- 117 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Dec 2011to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who provided a pretreatment tumor sample for Wilms' Tumor 1 (WT1) expression screening in the context of a neoadjuvant interventional study (111172 (WT1-AS15-BRS-001 (NEOADJ)), but who were not included into the active phase of this study.
Who may be able to join
- The patient has 18 years of age or older at the time of consent.
- The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study.
- The patient has a histologically or cytologically confirmed primary invasive breast cancer.
- The patient has provided written informed consent before any new information or new material is provided to the Sponsor.
- The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
- The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
Who cannot join
- Not applicable.
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
Germany9 sites
GSK Investigational Site
Chemnitz, Saxony, 09116
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Erlangen, Bavaria, 91054
GSK Investigational Site
Essen, North Rhine-Westphalia, 45136
GSK Investigational Site
Frankfurt am Main, Hesse, 60590
GSK Investigational Site
Homburg, Saarland, 66421
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059
GSK Investigational Site
Tübingen, Baden-Wurttemberg, 72076
Italy6 sites
GSK Investigational Site
Aviano (PN), Friuli Venezia Giulia, 33081
GSK Investigational Site
Milan, Lombardy, 20141
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Pavia, Lombardy, 27100
GSK Investigational Site
Rome, Lazio, 00189
GSK Investigational Site
Turin, Piedmont, 10126
United Kingdom5 sites
GSK Investigational Site
Bournemouth, BH7 7DW
GSK Investigational Site
Derby, DE22 3DT
GSK Investigational Site
Edinburgh, EH4 2XU
GSK Investigational Site
Nottingham, NG5 1PB
GSK Investigational Site
Poole, BH15 2JB
United States4 sites
GSK Investigational Site
Amarillo, Texas, 79106
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Newark, Delaware, 19713
GSK Investigational Site
Plantation, Florida, 33324
Russia3 sites
GSK Investigational Site
Ryazan, 390011
GSK Investigational Site
Saint Petersburg, 197022
GSK Investigational Site
Saint Petersburg, 197758
Belgium2 sites
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Namur, 5000
About this study
Official title: A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
- Conditions
- Neoplasms, Breast
- Keywords
- tumor antigens, observational, breast cancer, biomarkers, Neoadjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with primary invasive breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of a specific predictive gene expression signature in tumor tissues
Measured: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of immune infiltration in tumor tissues
Measured: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of other candidate biomarkers in tumor tissues
Measured: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The pathological response (complete response or partial response) in the breast.
Measured: At definitive surgery which may be up to 30 weeks post randomization.
Disease free interval
Measured: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
Disease free survival
Measured: Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.
Overall survival
Measured: Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Study termination due to negative Phase III of another study product from same technology platform.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, BreastStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 117 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
- NCT01476111
- Sponsor's protocol ID
- 115400
- Status last verified
- Feb 2015
- First submitted
- 10 Nov 2011
- Last updated
- 9 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Exploratory Observational Study Evaluating Specific Biomarkers in Primary Invasive Breast Cancer and Their Modulation by Standard Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT01476111
- Acronym / sponsor ID
- 115400
- Conditions
- Neoplasms, Breast
- Keywords
- tumor antigens, observational, breast cancer, biomarkers, Neoadjuvant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study termination due to negative Phase III of another study product from same technology platform.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 22 Nov 2011 (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.
This study will examine specific biomarkers in primary invasive breast cancer and explore their correlation with patient outcome following standard neoadjuvant treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with primary invasive breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who provided a pretreatment tumor sample for Wilms' Tumor 1 (WT1) expression screening in the context of a neoadjuvant interventional study (111172 (WT1-AS15-BRS-001 (NEOADJ)), but who were not included into the active phase of this study.
Key inclusion criteria (6 listed)
- The patient has 18 years of age or older at the time of consent.
- The patient has provided pre-treatment tumor samples for WT1 expression screening and gene expression profiling in the context of the NCT01220128 study.
- The patient has a histologically or cytologically confirmed primary invasive breast cancer.
- The patient has provided written informed consent before any new information or new material is provided to the Sponsor.
- The patient is planned to receive, is receiving or has received standard and/or investigational therapy for breast cancer.
Key exclusion criteria (1 listed)
- Not applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence of a specific predictive gene expression signature in tumor tissues
Time frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of immune infiltration in tumor tissues
Time frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The presence of other candidate biomarkers in tumor tissues
Time frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.
The pathological response (complete response or partial response) in the breast.
Time frame: At definitive surgery which may be up to 30 weeks post randomization.
Disease free interval
Time frame: Time from definitive surgery to the date of first recurrence of the disease up to maximally 6 years.
Disease free survival
Time frame: Time from definitive surgery to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurs first, up to maximally 6 years.
Overall survival
Time frame: Time from definitive surgery to the date of death, irrespective of the cause of death. Patients still alive will be censored at the date of the last contact up to maximally 6 years.
Results and safety
The study was stopped early (reason given: Study termination due to negative Phase III of another study product from same technology platform.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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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
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Breast, run by GlaxoSmithKline at 29 sites in 6 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Italy, United Kingdom, United States, Russia and 1 more country. 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 was stopped early (reason given: Study termination due to negative Phase III of another study product from same technology platform.). Results are not available in the source record.
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?
The presence of a specific predictive gene expression signature in tumor tissues (time frame: At randomization and at definitive surgery which may be up to 30 weeks post randomization.). The study lists 7 primary outcomes in all. 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 9 Mar 2015.