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.
Eligible Conditions
- Estrogen Receptor Positive Breast Cancer
- Estrogen Receptor 1 Gene Mutation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: up to 6 months
Week 6
Safety: Number of Participants Experiencing Grade 3 or higher Adverse Events
up to 6 months
Objective Response Rate at each dose level
Week 6
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
FES uptake at each dose level: Tumor-to-Normal tissue ratio
Rate of FES Blockade at each dose level to determine the Optimal Tamoxifen Dose
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Tamoxifen Dose Levels
1 of 1
Experimental Treatment
12 Total Participants · 1 Treatment Group
Primary Treatment: Tamoxifen · No Placebo Group · Phase < 1
Tamoxifen Dose LevelsExperimental Group · 2 Interventions: Tamoxifen, FES PET/CT · Intervention Types: Drug, DiagnosticTest
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tamoxifen
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,070 Previous Clinical Trials
2,576,629 Total Patients Enrolled
Kari Wisinski, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
6 Previous Clinical Trials
157 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have HER2 negative cancer.
You are informed of the investigational nature of the study and must be able to sign a written informed consent.
You have estrogen receptor expression greater than or equal to 10% by immunohistochemistry.
You have a tumor biopsy tissue or cfDNA with a mutation in the ESR1 gene.
Participants must have measurable disease as defined by RECIST 1.1 or evaluable bone disease with at least one lesion measuring 10 mm or greater in size
Participants must have received at least 1 prior line of endocrine therapy in the metastatic setting or have had progression within 12 months of adjuvant endocrine therapy
Participants with CNS metastases must be stable after therapy for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at least 1 month.
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Conditions
Cancer Related
Treatments