NCT03303846

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
344

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2017Nov 2026

First Submitted

Initial submission to the registry

October 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

October 13, 2017

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

9.1 years

First QC Date

October 3, 2017

Last Update Submit

April 20, 2026

Conditions

Healthy Subject

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 months

Secondary Outcomes (1)

  • Expression of WNT10B/mutant p53 in morphologically normal breast tissue

    Up to 12 months

Other Outcomes (1)

  • Predictive accuracy of WNT10B with magnetic resonance imaging (MRI)

    Up to 12 months

Study Arms (1)

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.

Procedure: Magnetic Resonance ImagingProcedure: Biospecimen CollectionOther: Laboratory Biomarker Analysis

Interventions

Magnetic Resonance ImagingPROCEDURE

Undergo high risk breast cancer screening MRI

Also known as: Magnetic Resonance / Nuclear Magnetic Resonance, MRI, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Treatment (breast MRI, biopsy)
Biospecimen CollectionPROCEDURE

Undergo blood and tissue sample collection

Treatment (breast MRI, biopsy)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (breast MRI, biopsy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Ohio State University, Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, 43212, United States

Location

University of Wisconsin

Madison, Wisconsin, 537192, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Victoria Seewaldt, MD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 6, 2017

Study Start

October 13, 2017

Primary Completion (Estimated)

November 20, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(5)