Breast CancerNCT02596724
TME Neoadjuvant Breast Registry
An observational study of Breast Cancer and Breast Neoplasms, run by Targeted Medical Education at 4 sites in United States.
Trial summary
Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Genomic and/or molecular testing of blood or tissue
- How many people
- 1,000 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2015to Jul 2022
- How long will I take part?
- 5 Years
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy. Aged 18-90.
Who may be able to join
- Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy
- Ages 18-90
- Written informed consent
Who cannot join
- Patients who have had excisional biopsy or axillary dissection
- Patients with confirmed metastatic disease
- Patients who have had recent chemotherapy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Coordinated Health Breast Care Specialists
Allentown, Pennsylvania, 18104
Dallas Surgical Group
Dallas, Texas, 75231
Valley Medical Oncology Consultants
Los Gatos, California, 95032
Nashville Breast Center
Nashville, Tennessee, 37203
About this study
Official title: TME Neoadjuvant Breast Registry (The NEAT Registry)
Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.
Read the detailed description
Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded.
Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website.
All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Genomic and/or molecular testing of blood or tissue
- Keywords
- Breast Cancer, Neoadjuvant therapy for breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic and/or molecular testing of blood or tissueOther
Genomic and/or molecular testing of blood or tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response and/or endocrine sensitivity
Measured: Post surgical treatment--usually within 4 months
Secondary outcomes (1)
Metastasis-free/relapse-free survival in molecular subgroups
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2022 (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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Targeted Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pat Whitworth, M.D., Principal investigator, Nashville Breast CenterPeter Beitsch, M.D., Principal investigator, Dallas Surgical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596724
- Sponsor's protocol ID
- TMENEO-100
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 5 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TME Neoadjuvant Breast Registry (The NEAT Registry)
- ClinicalTrials.gov ID
- NCT02596724
- Acronym / sponsor ID
- TMENEO-100
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- Breast Cancer, Neoadjuvant therapy for breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Targeted Medical EducationUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 4 Nov 2015 (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.
Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.
Detailed description
Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded.
Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website.
All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy. Aged 18-90.
Key inclusion criteria (3 listed)
- Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy
- Ages 18-90
- Written informed consent
Key exclusion criteria (3 listed)
- Patients who have had excisional biopsy or axillary dissection
- Patients with confirmed metastatic disease
- Patients who have had recent chemotherapy
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 |
|---|---|---|
| Genomic and/or molecular testing of blood or tissueGenomic and/or molecular testing of blood or tissue | Other | – |
Primary outcome
Pathologic response and/or endocrine sensitivity
Time frame: Post surgical treatment--usually within 4 months
1 secondary outcome
Metastasis-free/relapse-free survival in molecular subgroups
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 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.
Pat Whitworth, M.D. principal investigator
Nashville Breast Center
Peter Beitsch, M.D. principal investigator
Dallas Surgical Group
4 sites 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 and Breast Neoplasms, run by Targeted Medical Education at 4 sites 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 3 inclusion and 3 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 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Pathologic response and/or endocrine sensitivity (time frame: Post surgical treatment--usually within 4 months). 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 5 Nov 2015.