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

NCT01297231 | Withdrawn

• 2 other identifiers: 10-217Mskcc 10-217
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer

Keywords

fibroglandular tissue; tamoxifen; MRI; Background Parenchymal Enhancement; 10-217

Outcome Measures

Primary Outcomes (1)

• To compare the level of BPE on breast MRI

  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

  3 years

Secondary Outcomes (1)

• To compare the amount of fibroglandular tissue on breast MRI

  3 years

Study Arms (1)

Breast cancer

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.

Other: MRI

Interventions

MRI OTHER

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.

Breast cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible premenopausal patients with stage 0-3 breast cancer for whom MRI staging is planned will be enrolled.

You may qualify if:

• Females with stage 0-3 breast cancer who have had or are planned to have a breast MRI within 1 year prior to starting tamoxifen
• Premenopausal status is defined as intact ovaries and still menstruating
• Clinical and MRI follow-up planned at MSKCC or MCKCC regional facility
• Willing and able to undergo all study procedures

You may not qualify if:

• Contraindication to breast MRI (such as non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium)
• Bilateral breast cancer or treatment such as:
• History of or planned bilateral breast irradiation
• History of or planned bilateral mastectomy
• Bilateral breast cancer
• History of unilateral mastectomy or radiation treatment with contralateral breast cancer
• Taking chemo- or hormonal therapy at the time of the baseline breast MRI
• Estrogen and progesterone receptor negative breast cancer
• GFR less than GFR \< 30 mL/min/1.73m2
• Postmenopausal women
• Pregnant and/or nursing women
• Less than 21 years of age

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Related Links

• Memorial Sloan-Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

blood or saliva

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Valencia King, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 16, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 14, 2012

Record last verified: 2012-11