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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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fibroglandular tissue tamoxifen MRI Background Parenchymal Enhancement 10-217

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valencia King, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Countries

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United States

Other Identifiers

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Mskcc 10-217

Identifier Type: OTHER

Identifier Source: secondary_id

10-217

Identifier Type: -

Identifier Source: org_study_id