We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03303846
Recruitment Status : Recruiting
First Posted : October 6, 2017
Last Update Posted : November 25, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Subject Procedure: Magnetic Resonance Imaging Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.

SECONDARY OBJECTIVES:

I. 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:

I. 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment (breast MRI, biopsy)
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 Imaging
Undergo high risk breast cancer screening MRI
Other Names:
  • Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Biospecimen Collection
Undergo blood and tissue sample collection

Other: Laboratory Biomarker Analysis
Correlative studies


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Expression of WNT10B/mutant p53 in morphologically normal breast tissue [ Time Frame: Up to 12 months ]
    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.


Other Outcome Measures:
  1. Predictive accuracy of WNT10B with magnetic resonance imaging (MRI) [ Time Frame: Up to 12 months ]
    The specificity for MRI combined with WNT10B and/or p53 based biomarkers to detect triple negative breast cancer (TNBC) will be calculated with 95% confidence interval (CI). Its prediction accuracy will be described by C-index and compared to that by diagnosis by MRI alone.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03303846


Locations
Layout table for location information
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Tanya Chavez    626-218-0634    tachavez@coh.org   
Principal Investigator: Victoria Seewaldt, MD         
Sub-Investigator: Lisa Yee, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Kristy Watkins    323-865-0452    Watkins_K@med.usc.edu   
Principal Investigator: Julie E. Lang, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Jennifer Gallagher    919-970-1551    jennifer.gallagher@duke.edu   
Principal Investigator: Terry Hyslop, PhD         
United States, Ohio
Ohio State University, Stefanie Spielman Comprehensive Breast Center Recruiting
Columbus, Ohio, United States, 43212
Contact: Sarah Woelke    419-308-4708    sarah.woelke@osumc.edu   
Principal Investigator: Steven K. Clinton, MD         
Sub-Investigator: Lisa Yee, MD         
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 537192
Contact: Renae Quale    608-263-7898    rmquale@wisc.edu   
Principal Investigator: Ruth O'Regan, MD         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Victoria Seewaldt, MD City of Hope Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03303846    
Other Study ID Numbers: 17009
NCI-2017-01757 ( Registry Identifier: NCI CTRP )
U01CA189283 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2017    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No