Breast CancerNCT04803084
Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment
An observational study of Breast Cancer and Triple-negative Breast Cancer, run by Laura Kennedy at 1 site in United States.
Trial summary
This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple-negative Breast Cancer
- What is being tested?
- Tempus assay, Advanced pathology 1 and Advanced pathology 2
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to Aug 2027
- 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: Women and men at least 18 years of age that have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only.
Who may be able to join
- Women and men at least 18 years of age.
- Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
- Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
- Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
- Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
- Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
Show all 10Show fewer
- Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
- Be a candidate for MRI imaging.
- Be willing to comply with scheduled visits required for the trial.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.
- Poor visualization of the tumor on the initial breast MRI (investigator discretion)
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer
This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.
Read the detailed description
Primary Objective:
- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent
Secondary Objective:
- To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
- To assess the prognostic potential of MRI features
Correlative:
- To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
- To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response
- Conditions
- Breast Cancer, Triple-negative Breast Cancer
- Being tested
- Tempus assay, Advanced pathology 1, Advanced pathology 2
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tempus assayOther
Blood collection
Advanced pathology 1Other
Tissue procurement (from diagnostic biopsy)
Advanced pathology 2Other
Tissue procurement (from research biopsy)
| Study group | Role | What they receive |
|---|---|---|
| Advanced Pathology | Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response. Receives: Other: Tempus assay; Other: Advanced pathology 1; Other: Advanced pathology 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate dynamic-contrast enhanced MRI characteristics
Measured: Baseline up to about 14 weeks
Correlate diffusion weight imaging MRI characteristics
Measured: Baseline up to about 14 weeks
Secondary outcomes (2)
Evaluate association between MRI features and pathologic response
Measured: Baseline up to about 14 weeks
Evaluate association between MRI features and recurrence-free survival
Measured: Baseline up to about 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start9 Aug 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: MRI upgrade
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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laura Kennedy
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Laura Kennedy, Vanderbilt-Ingram Cancer Center
- Investigators
- Laura Kennedy, MD, PhD, Principal investigator, Vanderbilt Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803084
- Sponsor's protocol ID
- VICC BRE 20104
- Other IDs
- P50CA098131
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer
- ClinicalTrials.gov ID
- NCT04803084
- Acronym / sponsor ID
- VICC BRE 20104
- Conditions
- Breast Cancer, Triple-negative Breast Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: MRI upgrade
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Laura KennedyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 17 Mar 2021 (actual)
- 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 is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.
Detailed description
Primary Objective:
- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent
Secondary Objective:
- To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
- To assess the prognostic potential of MRI features
Correlative:
- To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
- To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Pathology | – | Other: Tempus assay, Other: Advanced pathology 1, Other: Advanced pathology 2Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women and men at least 18 years of age that have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only.
Key inclusion criteria (10 listed)
- Women and men at least 18 years of age.
- Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
- Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
- Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
- Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
Key exclusion criteria (3 listed)
- Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.
- Poor visualization of the tumor on the initial breast MRI (investigator discretion)
- Pregnant or nursing.
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 |
|---|---|---|
| Tempus assayBlood collection | Other | Advanced Pathology |
| Advanced pathology 1Tissue procurement (from diagnostic biopsy) | Other | Advanced Pathology |
| Advanced pathology 2Tissue procurement (from research biopsy) | Other | Advanced Pathology |
Primary outcome
Correlate dynamic-contrast enhanced MRI characteristics
Time frame: Baseline up to about 14 weeks
Correlate diffusion weight imaging MRI characteristics
Time frame: Baseline up to about 14 weeks
2 secondary outcomes
Evaluate association between MRI features and pathologic response
Time frame: Baseline up to about 14 weeks
Evaluate association between MRI features and recurrence-free survival
Time frame: Baseline up to about 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Laura Kennedy, MD, PhD principal investigator
Vanderbilt Medical Center
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 and Triple-negative Breast Cancer, run by Laura Kennedy 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 10 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: paused, as of the sponsor's last update on 19 Aug 2026. 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?
Correlate dynamic-contrast enhanced MRI characteristics (time frame: Baseline up to about 14 weeks). The study lists 2 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 19 Aug 2026.