Impact of Low-dose Tamoxifen on BPU

NCT ID: NCT02979301

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-11-01

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.

Conditions

High Background Uptake on MBI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tamoxifen 5 mg/day

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

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

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

Tamoxifen 10 mg/day

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

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

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

Interventions

Tamoxifen

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Carrie Hruska

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carrie Hruska, PhD R-D

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30850011 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

IRB 16-008736

Identifier Type: -

Identifier Source: org_study_id