NCT02979301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

November 29, 2016

Results QC Date

April 29, 2019

Last Update Submit

April 29, 2019

Conditions

High Background Uptake on MBI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Tamoxifen 5 mg/day

EXPERIMENTAL

Women with high background uptake on MBI take 5 mg tam per day for 30 days.

Drug: Tamoxifen

Tamoxifen 10 mg/day

EXPERIMENTAL

Women with high background uptake on MBI take 10 mg tam per day for 30 days.

Drug: Tamoxifen

Interventions

TamoxifenDRUG

5 mg or 10 mg tamoxifen per day for 30 days.

Tamoxifen 10 mg/dayTamoxifen 5 mg/day

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Hruska CB, Hunt KN, Conners AL, Geske JR, Brandt KR, Degnim AC, Vachon CM, O'Connor MK, Rhodes DJ. Impact of short-term low-dose tamoxifen on molecular breast imaging background parenchymal uptake: a pilot study. Breast Cancer Res. 2019 Mar 8;21(1):38. doi: 10.1186/s13058-019-1120-5.

    PMID: 30850011DERIVED

Related Links

MeSH Terms

Interventions

Tamoxifen

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Carrie Hruska
Organization
Mayo Clinic
hruska.carrie@mayo.edu
507-293-4719

Study Officials

  • Carrie Hruska, PhD R-D

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

March 1, 2017

Primary Completion

February 25, 2018

Study Completion

November 1, 2018

Last Updated

July 16, 2019

Results First Posted

July 16, 2019

Record last verified: 2019-04

Locations

US(1)