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 : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subject||Procedure: Magnetic Resonance Imaging Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis||Not Applicable|
I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years.
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.
I. To determine the predictive accuracy of WNT10B with MRI, of which will be compared with MRI alone using the C-index.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||650 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Breast MRI/Biomarker Strategies to Identify Aggressive Biology|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
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
Procedure: Biospecimen Collection
Undergo blood and tissue sample collection
Other: Laboratory Biomarker Analysis
- 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.
- 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.
- 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.
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
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Tanya Chavez 626-218-0634 firstname.lastname@example.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|
|Durham, North Carolina, United States, 27705|
|Contact: Jennifer Gallagher 919-970-1551 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Steven K. Clinton, MD|
|Sub-Investigator: Lisa Yee, MD|
|United States, Wisconsin|
|University of Wisconsin||Not yet recruiting|
|Madison, Wisconsin, United States, 537192|
|Contact: Renae Quale 608-263-7898 email@example.com|
|Principal Investigator: Ruth O'Regan, MD|
|Principal Investigator:||Victoria Seewaldt, MD||City of Hope Medical Center|