Breast CancerNCT02108561
Breast Cancer Tumor Heterogeneity
An observational study of Breast Cancer, run by Anne Arundel Health System Research Institute at 1 site in United States.
Trial summary
Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Post Surgical Her2 testing
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2018
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer pre-surgical patients
Who may be able to join
- Women > age 18 with capacity to consent
- Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
- IHC biomarkers performed on original CNB (including HER2)
- Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
- Multifocal or multicentric tumors
Who cannot join
- Men
- Women with HER2 positive tumors detected on CNB specimens
- Women receiving neoadjuvant chemotherapy
- Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
- Women whose IHC marker results were inconclusive on CNB or not performed -
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne Arundel Medical Center
Annapolis, Maryland, 21401
About this study
Official title: Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?
Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.
- Conditions
- Breast Cancer
- Being tested
- Post Surgical Her2 testing
- Keywords
- Breast Cancer Heterogeneity Her2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Surgical Her2 testingOther
Eligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer | Post Surgical Her2 testing Receives: Other: Post Surgical Her2 testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benefit of additional Her2 testing
To identify a subset of women with invasive breast cancer who may benefit from additional Her2 testing (by immunochemistry and FISH) on their surgical specimen to ensure that areas of Her2 amplification are not missed due to sampling error of the core needle biopsy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion22 Dec 2017
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Arundel Health System Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108561
- Sponsor's protocol ID
- 505185
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2014
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Breast Tumor Heterogeneity Necessitate Additional HER2 Testing on the Surgical Specimens?
- ClinicalTrials.gov ID
- NCT02108561
- Acronym / sponsor ID
- 505185
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Heterogeneity Her2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Anne Arundel Health System Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2014
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Apr 2014 (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.
Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Other: Post Surgical Her2 testingPost Surgical Her2 testing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer pre-surgical patients
Key inclusion criteria (5 listed)
- Women > age 18 with capacity to consent
- Invasive breast cancer identified on CNB at AAMC within 45 days of study consent
- IHC biomarkers performed on original CNB (including HER2)
- Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or
- Multifocal or multicentric tumors
Key exclusion criteria (5 listed)
- Men
- Women with HER2 positive tumors detected on CNB specimens
- Women receiving neoadjuvant chemotherapy
- Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment
- Women whose IHC marker results were inconclusive on CNB or not performed -
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 |
|---|---|---|
| Post Surgical Her2 testingEligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes | Other | Breast Cancer |
Primary outcome
Benefit of additional Her2 testing
Time frame: 2 years
To identify a subset of women with invasive breast cancer who may benefit from additional Her2 testing (by immunochemistry and FISH) on their surgical specimen to ensure that areas of Her2 amplification are not missed due to sampling error of the core needle biopsy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Anne Arundel Health System Research Institute at 1 site in United States.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
Benefit of additional Her2 testing (time frame: 2 years). 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 Jan 2018.