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

NCT01297231 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2012-11-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

MRI

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.

Sponsors & Collaborators

Principal Investigators

  • Valencia King, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2014-02-28
Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297231 on ClinicalTrials.gov