Healthy SubjectNCT03303846
Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients
A study testing Magnetic Resonance Imaging, Biospecimen Collection and Laboratory Biomarker Analysis in people with Healthy Subject, run by City of Hope Medical Center at 5 sites in United States.
Trial summary
This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject
- What is being tested?
- Magnetic Resonance Imaging, Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 May 2017to 20 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
- Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
- Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
- Documented informed consent of the participant
Who cannot join
- Allergy or intolerance to gadolinium
- Inability to undergo breast MRI (e.g. claustrophobia)
- Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
- Previous diagnosis of stage 4 cancer
- Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
- Participants who have received endocrine therapy within 1 year prior to screening breast MRI
Show all 10Show fewer
- Participants who have received breast radiation within 1 year prior to screening breast MRI
- Radiation to both breasts
- Pregnant and/or lactating within 1 year prior to screening breast MRI
- Receives screening breast MRIs at an outside facility other than the consenting institution
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
City of Hope Medical Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27705
University of Southern California
Los Angeles, California, 90033
University of Wisconsin
Madison, Wisconsin, 537192
About this study
Official title: Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
This clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.
SECONDARY OBJECTIVES:
- To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years.
TERTIARY OBJECTIVES:
- To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index.
OUTLINE:
Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants undergo collection of breast tissue samples at any breast biopsy or breast surgery.
- Conditions
- Healthy Subject
- Being tested
- Magnetic Resonance Imaging, Biospecimen Collection, Laboratory Biomarker Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance / Nuclear Magnetic Resonance, MRI, NMR Imaging, NMRI
Undergo high risk breast cancer screening MRI
Biospecimen CollectionProcedure or surgery
Undergo blood and tissue sample collection
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (breast MRI, biopsy) | Experimental | Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery. Receives: Procedure: Magnetic Resonance Imaging; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
Development of breast cancers other than triple-negative (e.g. estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) the study analysis, however they will be reported as descriptive statistics.
Measured: Up to 12 months
Secondary outcomes (1)
Expression of WNT10B/mutant p53 in morphologically normal breast tissue
Biopsy tissue will be assessed for 1) activated WNT10B (measured by presence of high phospho-beta-catenin; present vs. absent) and 2) loss of p53 function (measured by the loss of p21 expression; present versus [vs.] absent). The optimal cut for the WNT10B to differentiate progression vs. non-progression women will be carried out by receiver operating characteristic (ROC) analysis, and hence WNT10B expression will be dichotomized to high vs. low expression. Chi-square test 12-month progression. Adjusted association will be further explored by logistic regression incorporating subject characteristics, such as age, body mass index (BMI), race, and BRCA1.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start11 May 2017
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Victoria Seewaldt, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303846
- Sponsor's protocol ID
- 17009
- Other IDs
- NCI-2017-01757, U01CA189283
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2017
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
- ClinicalTrials.gov ID
- NCT03303846
- Acronym / sponsor ID
- 17009
- Conditions
- Healthy Subject
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 344 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2017 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 6 Oct 2017 (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 clinical trial studies normal breast tissue changes combined with breast magnetic resonance imaging (MRI) that may suggest the beginnings of cancer development. Using breast tissue markers in combination with breast imaging such as MRI may help to more accurately assess a woman's risk of developing breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.
SECONDARY OBJECTIVES:
- To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer over 7 years.
TERTIARY OBJECTIVES:
- To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index.
OUTLINE:
Participants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants undergo collection of breast tissue samples at any breast biopsy or breast surgery.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (breast MRI, biopsy) | Experimental | Procedure: Magnetic Resonance Imaging, Procedure: Biospecimen Collection, Other: Laboratory Biomarker AnalysisParticipants undergo standard of care high risk breast cancer screening MRIs at baseline and follow-up and blood sample collection at baseline. Participants also undergo collection of breast tissue samples at any breast biopsy or breast surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who are undergoing screening breast MRI as per standard of care for high-risk breast cancer screening
- Willing to donate left-over tissue if patient undergoes a breast biopsy and/or breast surgery
- Willing to have about 40 mL of blood (approximately 3 tablespoons) drawn
- Documented informed consent of the participant
Key exclusion criteria (10 listed)
- Allergy or intolerance to gadolinium
- Inability to undergo breast MRI (e.g. claustrophobia)
- Participants with active cancer diagnosis (exception: skin cancer, biopsy-proven atypical lobular, ductal hyperplasia and/or lobular carcinoma in situ)
- Previous diagnosis of stage 4 cancer
- Participants who have received cytotoxic chemotherapy within 1 year prior to screening breast MRI
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: Magnetic Resonance / Nuclear Magnetic Resonance, MRI, NMR Imaging, NMRIUndergo high risk breast cancer screening MRI | Procedure or surgery | Treatment (breast MRI, biopsy) |
| Biospecimen CollectionUndergo blood and tissue sample collection | Procedure or surgery | Treatment (breast MRI, biopsy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (breast MRI, biopsy) |
Primary outcome
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study
Time frame: Up to 12 months
Development of breast cancers other than triple-negative (e.g. estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) the study analysis, however they will be reported as descriptive statistics.
1 secondary outcome
Expression of WNT10B/mutant p53 in morphologically normal breast tissue
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Healthy Subject
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Victoria Seewaldt, MD principal investigator
City of Hope Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging, Biospecimen Collection and Laboratory Biomarker Analysis in people with Healthy Subject, run by City of Hope Medical Center at 5 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 4 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of triple-negative breast cancer (invasive and/or ductal carcinoma in situ [DCIS]) within the 12-month period of the study (time frame: Up to 12 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 20 Oct 2026.