Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

To complete the study women need to have undergone their scheduled contrast-enhanced MRI, completed the study questionnaire, and provided written consent to release MRIs/mammograms. Although attempts will be made to obtain written consent from all women, the questionnaire data captured from the women who only provide verbal consent may be used in analysis. Optional saliva samples will also be collected for future use.

Jonine Bernstein, PhD

The purpose of the study is to view what normal breast tissue looks like on an MRI and mammogram to help determine how it may affect the risk of developing breast cancer. The investigators will also compare the information collected from the questionnaire and medical records to help better understand how this may affect the risk of developing breast cancer. If a saliva or tissue sample is collected for future use, this information will enable us to study genetic risk factors as well.

Proposed Study Methods Pertaining to the Population, Eligibility and Recruitment In this multi-center hospital-based case-control study, cases will be women diagnosed with incident breast cancer who have undergone or are about to undergo a bilateral breast MRI with contrast to assess extent of disease. The cancer-free controls will be women at high-risk of breast cancer undergoing a bilateral breast MRI with contrast for screening. The MRI collected for the study may be post-biopsy and post-surgery (unilateral lumpectomy/mastectomy), but prior to bilateral mastectomy, radiation, hormonal, and/or chemotherapy. Study participants also need to have a bilateral mammogram available at the study site within 24 months prior to, or up to 24 months after the study MRI (as long as prior to surgery, radiation, hormonal, and/or chemotherapy), to be included in the secondary aim analysis. The MRI/mammogram selected for this study do not need to be conducted at the recruitment site, the digital images just need to be accessible from the patient medical records at the site. Questionnaire data, optional saliva samples, MRIs, mammograms, and medical records will be collected over a 27 month period from women at three NCI-designated comprehensive cancer centers (MSK, Penn, Utah). Each site has demonstrated experience with recruitment, patient interviews and collection of MRIs and mammograms.

MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study

University of Pennsylvania

University of Utah

University of Toronto

Memorial Sloan Kettering Cancer Center

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

This prospective study will recruit patients with stage 0-3 breast cancer who have had or are scheduled for a breast MRI prior to treatment.

Baseline Breast-MRI within 1 year before starting tamoxifen (allows for surgery, chemotherapy and radiation before the start of tamoxifen).

During Tamoxifen Treatment:

* Blood will be drawn for CYP2D6 genotype testing. Analysis of samples will be performed internally at MSKCC.
* Follow-up breast MRI after 9-12 months of tamoxifen therapy. In patients whom further breast MRI screening and/or follow-up is clinically indicated, follow-up breast MRIs may be performed within 3 months (before or after) the 2, 3, and 4 year time points during tamoxifen treatment. All breast MRIs will be performed using the same technique.
* Follow-up for all patients during and after tamoxifen should include routine standard clinical assessment and imaging such as mammography and breast MRI when clinically indicated.

Valencia King, MD

Tamoxifen is a hormonal treatment for breast cancer. It prevents recurrent disease and decreases death. Tamoxifen is given to women with and at high risk for breast cancer. These women also commonly have breast MRI to monitor for breast cancer. Some features of normal breast tissue visible on breast MRI change depending on patient hormonal status. It has been questioned if hormonal changes due to tamoxifen are seen on breast MRI. Pilot data suggests this is true. If tamoxifen causes changes in normal breast tissue on MRI, more study could be done looking at whether breast MRI could tell us anything about whether tamoxifen is working.

This study is being done to see if tamoxifen changes normal breast tissue on MRI. It will also look at if other factors like taking anti-depressants or gene type have any effect.

Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI

Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI in Early Stage Breast Cancer Patients on Tamoxifen

on breast MRI in premenopausal patients with breast cancer before and during 9-12 months on tamoxifen to determine whether tamoxifen results in a significant decrease in BPE and/or amount of fibroglandular tissue

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study	NCT02301767	Breast Cancer		21 Years - 69 Years	Memorial Sloan Kettering Cancer Center
Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI	NCT01297231	Breast Cancer	MRI	21 Years -	Memorial Sloan Kettering Cancer Center
MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study	NCT02301767	Breast Cancer		21 Years - 69 Years	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for background parenchymal enhancement