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Impact of Low-dose Tamoxifen on BPU

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: NCT02979301
Recruitment Status : Completed
First Posted : December 1, 2016
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
High Background Uptake on MBI Drug: Tamoxifen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Low-Dose Tamoxifen to Reduce High Background Parenchymal Uptake on Molecular Breast Imaging
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : February 25, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tamoxifen 5 mg/day
Women with high background uptake on MBI take 5 mg tam per day for 30 days.
Drug: Tamoxifen
5 mg or 10 mg tamoxifen per day for 30 days.

Experimental: Tamoxifen 10 mg/day
Women with high background uptake on MBI take 10 mg tam per day for 30 days.
Drug: Tamoxifen
5 mg or 10 mg tamoxifen per day for 30 days.




Primary Outcome Measures :
  1. Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI) [ Time Frame: 30 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:The following are requirements for entry into the study:

  1. Female, age 40 or older at the time of enrollment
  2. Most recent MBI examination, performed within 3 years of enrollment, showed moderate or marked background parenchymal uptake
  3. Mammogram performed within 12 months prior to enrollment that is available for comparison
  4. Willing and able to return for MBI following 30 days of low-dose tamoxifen
  5. If able to become pregnant

    1. Negative pregnancy test within 48 hours prior to study MBI exam(s)
    2. Agrees to avoid pregnancy during the study and for at least 2 months after study participation ends, by abstinence, barrier method, or nonhormonal contraception.
  6. 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:

  1. Systemic hormonal therapy (oral or transdermal patch formulations)
  2. Hormonal contraception (oral, transdermal, implanted, or injected formulations)
  3. Selective estrogen receptor modulators (tamoxifen, raloxifene, or toremifene)
  4. Aromatase inhibitors (anastrazole, letrozole, or exemestane)
  5. GnRH analogs
  6. Prolactin inhibitors
  7. Androgens or antiandrogens
  8. Anticoagulants or "blood thinners" (warfarin, heparin, rivaroxaban and other novel anticoagulants)
  9. 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.

Information from the National Library of Medicine

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): NCT02979301


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Carrie Hruska, PhD R-D Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Carrie Hruska, Mayo Clinic:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carrie Hruska, Associate Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02979301    
Other Study ID Numbers: IRB 16-008736
First Posted: December 1, 2016    Key Record Dates
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents