Prospective Analysis of Changes in Background Parenchymal Enhancement (BPE) and Amount of Fibroglandular Tissue on Breast MRI
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01297231|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : February 16, 2011
Last Update Posted : November 14, 2012
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: MRI|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||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|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
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:
- To compare the level of BPE on breast MRI [ Time Frame: 3 years ]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
- To compare the amount of fibroglandular tissue on breast MRI [ Time Frame: 3 years ]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
Biospecimen Retention: Samples With DNA
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): NCT01297231
|Principal Investigator:||Valencia King, MD||Memorial Sloan Kettering Cancer Center|