MBI Response toTam



Status:Enrolling by invitation
Healthy:No
Age Range:40 - Any
Updated:12/13/2018
Start Date:March 1, 2017
End Date:February 2019

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
1
site
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials