Impact of Low-dose Tamoxifen on BPU

Study Overview
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Brief Summary
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The study will examine whether changes in background parenchymal uptake (BPU) on molecular breast imaging (MBI) can be induced by short-term use of low-dose tamoxifen. Women who have previously had high BPU on MBI will be recruited. Participants will take low-dose tamoxifen for a 30-day period, with post-tamoxifen MBI in order to investigate the impact of tamoxifen on BPU.

Official Title
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Low-Dose Tamoxifen to Reduce High Background Parenchymal Uptake on Molecular Breast Imaging

Conditions
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High Background Uptake on MBI

Intervention / Treatment
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* Drug: Tamoxifen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:The following are requirements for entry into the study: Female, age 40 or older at the time of enrollment Most recent MBI examination, performed within 3 years of enrollment, showed moderate or marked background parenchymal uptake Mammogram performed within 12 months prior to enrollment that is available for comparison Willing and able to return for MBI following 30 days of low-dose tamoxifen If able to become pregnant Negative pregnancy test within 48 hours prior to study MBI exam(s) Agrees to avoid pregnancy during the study and for at least 2 months after study participation ends, by abstinence, barrier method, or nonhormonal contraception. Understands and signs the consent form - Exclusion Criteria:Subjects will be excluded if any of the following characteristics are present: 1) Evidence of suspected breast disease as defined by positive findings or recommendation for short-interval follow-up on most recent breast imaging (including mammography, MBI, MRI, ultrasound, etc.) not yet resolved prior to enrollment 2) Breast biopsy or breast surgery performed 6 months prior to enrollment 3) Bilateral breast implants or status post-bilateral prophylactic mastectomy 4) Pregnant or lactating 5) Current or recent use (within 6 months prior to enrollment) of any of the following drugs: Systemic hormonal therapy (oral or transdermal patch formulations) Hormonal contraception (oral, transdermal, implanted, or injected formulations) Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene) Aromatase inhibitors (anastrazole, letrozole, or exemestane) GnRH analogs Prolactin inhibitors Androgens or antiandrogens Anticoagulants or blood thinners (warfarin, heparin, rivaroxaban and other novel anticoagulants) Drugs known to be strong inhibitors of CYP2D6, the major P450 enzyme that metabolizes tamoxifen, including: bupropion (Wellbutrin) fluoxetine (Prozac) paroxetine (Paxil) quinidine (Quinidex) 6) Personal history of any type of malignancy, with the exclusion of non-melanoma skin cancer, diagnosed prior to enrollment 7) Personal history or strong family history of blood clots in legs or lungs (also known as deep vein thrombosis or pulmonary embolism) 8) Personal history of transient ischemic attack (TIA) or cerebrovascular accident (CVA) 9) Active proliferative disorders of the endometrium such as atypical hyperplasia, history of active endometriosis, unresected polyps 10) Any type of retinal disorders or severe cataract 11) Current or former smoker 12) Known carrier of BRCA1 or BRCA2 genetic mutation or known DNA repair defect.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen 5 mg/day<br>Women with high background uptake on MBI take 5 mg tam per day for 30 days. | Drug: Tamoxifen<br>* 5 mg or 10 mg tamoxifen per day for 30 days.<br>|
| Experimental: Tamoxifen 10 mg/day<br>Women with high background uptake on MBI take 10 mg tam per day for 30 days. | Drug: Tamoxifen<br>* 5 mg or 10 mg tamoxifen per day for 30 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI) | An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined. | 30 days |