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Selective Estrogen Receptor Modulator
FES Imaging + Tamoxifen for Breast Cancer
Phase < 1
Recruiting
Led By Kari Wisinski, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estrogen receptor expression by immunohistochemistry greater than or equal to 10%
Participants with liver-only disease are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial is testing whether a new imaging technique can help optimize tamoxifen dosing for breast cancer patients with a certain type of genetic mutation.
Who is the study for?
This trial is for individuals with metastatic or unresectable breast cancer that tests positive for estrogen receptor expression and has an ESR1 mutation. They must have had prior endocrine therapy, be stable after CNS metastases treatment, and able to take oral medications. Excluded are those with liver-only disease, recent other treatments, severe allergies to similar compounds as tamoxifen or FES-PET/CT components, certain health conditions, or concurrent malignancies.Check my eligibility
What is being tested?
The study investigates the use of FES-PET/CT imaging to measure ERα blockade in order to find the optimal dose of tamoxifen for patients with ESR1 mutations. It's a pilot study aiming at improving dosing strategies by using advanced imaging techniques on participants who may not respond well to standard doses due to these specific gene mutations.See study design
What are the potential side effects?
Tamoxifen can cause side effects such as vaginal bleeding and increase the risk of uterine malignancy; it also poses risks during pregnancy like birth defects and fetal loss. Other potential side effects include blood clots and vision problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer tests show at least 10% estrogen receptor presence.
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My cancer has not spread to my liver only.
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I am fully active or can carry out light work.
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I have had hormone therapy for my cancer that has spread or returned within a year.
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My breast cancer cannot be removed by surgery and has spread.
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My cancer has an ESR1 mutation, confirmed by a certified test.
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My cancer is not HER2 positive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of FES Blockade at each dose level to determine the Optimal Tamoxifen Dose
Secondary outcome measures
FES uptake at each dose level: SUVmax
FES uptake at each dose level: SUVmean
FES uptake at each dose level: Tumor-to-Blood Pool ratio
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tamoxifen Dose LevelsExperimental Treatment2 Interventions
Three participants will be enrolled to each dose level of oral tamoxifen (n = 12)
Dose Level 1 = 20 mg daily Dose Level 2 = 80 mg daily Dose Level 3 = 160 mg daily Dose Level 4 = 200 mg daily
Tamoxifen should be started within 14 days of the FES-PET/CT scan, at least 24 hours after FES injection. Participants will continue tamoxifen therapy until there is radiologic or clinical evidence of progressive disease or drug intolerance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,187 Previous Clinical Trials
3,169,485 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer
Kari Wisinski, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
6 Previous Clinical Trials
157 Total Patients Enrolled
2 Trials studying Breast Cancer
35 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take pills by mouth.I am aware that Tamoxifen can cause vaginal bleeding and harm to a fetus.I do not have any unmanaged serious illnesses.My cancer tests show at least 10% estrogen receptor presence.My nerve damage does not severely affect my daily activities.My organs and bone marrow are functioning well.I haven't taken ER blocking therapy for at least 60 days.I haven't had cancer treatment or major surgery in the last 2 to 4 weeks.My cancer has not spread to my liver only.I do not have severe eye conditions like advanced retinopathy or macular degeneration.I am fully active or can carry out light work.I am allergic to medications similar to tamoxifen or [18F]-fluoroestradiol.You have a history of ongoing problems with balance, coordination, or uncontrolled seizures, unless they are related to a temporary medical condition and your doctor doesn't think they are currently a problem.You are currently taking any other experimental drugs.I cannot take certain medications due to health risks.I had uterine cancer but have been clear for over 3 years after my hysterectomy.My brain metastases have been stable for at least 1 month after treatment.I have a cancer lesion that is at least 10 mm big.I have had hormone therapy for my cancer that has spread or returned within a year.You are expected to live for more than 12 weeks.You have a heart condition that could make your heart rhythm go out of sync.My breast cancer cannot be removed by surgery and has spread.My cancer has an ESR1 mutation, confirmed by a certified test.I have had a blood clot or stroke in the past.I have no cancer other than skin cancer or cervical cancer that hasn't spread.My cancer is not HER2 positive.
Research Study Groups:
This trial has the following groups:- Group 1: Tamoxifen Dose Levels
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this investigation for participants?
"Affirmative. The information held on clinicaltrials.gov shows that this research venture is presently enrolling participants. It was originally posted to the platform on October 20th 2020 and most recently updated on July 25th 2022, with 12 people sought from two locations."
Answered by AI
What is the cap on enrollment for this clinical trial?
"Affirmative. The clinicaltrials.gov database shows that this study is presently recruiting participants, having first been posted on October 20th 2020 and last updated July 25th 2022. To date, 12 qualified individuals from two medical centres are being sought out for the trial."
Answered by AI
For which medical conditions is Tamoxifen commonly prescribed?
"Tamoxifen is often utilized to manage malignant neoplasms. This medication may also be beneficial for those with ovarian cancer, requiring ovulation induction therapy, or who are considered high risk."
Answered by AI
Are there any other precedent studies using Tamoxifen for research purposes?
"Currently, 22 out of 67 active studies for Tamoxifen are in Phase 3. Of the 7300 clinical trial sites worldwide that offer this medication, most are located around Pittsburgh, Pennsylvania."
Answered by AI
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