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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen 5 mg/day | Experimental | Women with high background uptake on MBI take 5 mg tam per day for 30 days. |
|
| Tamoxifen 10 mg/day | Experimental | Women with high background uptake on MBI take 10 mg tam per day for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | 5 mg or 10 mg tamoxifen per day for 30 days. |
|
| 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 |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Hruska, PhD R-D | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30850011 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen 5 mg/Day | Women with a history of high background uptake on MBI were enrolled. A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. |
| FG001 | Tamoxifen 10 mg/Day | Women with a history of high background uptake on MBI were enrolled. A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen 5 mg/Day | Women with a history of high background uptake on MBI were enrolled. A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. |
| BG001 | Tamoxifen 10 mg/Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent change in BPU | 30 days |
|
Adverse events were collected from baseline until the last study visit for each study subject, approximately 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamoxifen 5 mg/Day | Women with a history of high background uptake on MBI were enrolled. A baseline MBI was performed at Day 0. Women then took 5 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carrie Hruska | Mayo Clinic | 507-293-4719 | hruska.carrie@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2017 | Mar 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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Women with a history of high background uptake on MBI were enrolled. A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Tamoxifen 10 mg/Day | Women with a history of high background uptake on MBI were enrolled. A baseline MBI was performed at Day 0. Women then took 10 mg tamoxifen per day for 30 days, followed by a post-tamoxifen MBI exam. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |