Trials Sponsors Conditions Drugs Pricing

Conditions

ERα+ Breast Cancer ESR1 Gene Mutation

Outcome Measures

Primary Outcomes (1)

Rate of FES Blockade at each dose level to determine the Optimal Tamoxifen Dose
Reduction in FES uptake will be described and analyzed by Fisher's exact test. Rates or proportion of responses at each dose level will be provided in data listings. If the SUVmax for all 5 target lesions have decreased by \> 75% or all 5 lesions have SUVmax\<1.5 on the second scan, then these participants will be prospectively defined as having complete FES blockade. If the SUVmax for any of the 5 lesions has not decreased by \> 75% or if any new lesions arise with SUVmax ≥1.5, then these subjects will be defined as having incomplete FES blockade.
up to 6 weeks to compare baseline and treatment images

Secondary Outcomes (6)

FES uptake at each dose level: SUVmax
up to 6 weeks to compare baseline and treatment images
FES uptake at each dose level: SUVmean
up to 6 weeks to compare baseline and treatment images
FES uptake at each dose level: Tumor-to-Normal tissue ratio
up to 6 weeks to compare baseline and treatment images
FES uptake at each dose level: Tumor-to-Blood Pool ratio
up to 6 weeks to compare baseline and treatment images
Objective Response Rate at each dose level
up to 6 months
+1 more secondary outcomes

Study Arms (1)

Tamoxifen Dose Levels

EXPERIMENTAL

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.

Drug: TamoxifenDiagnostic Test: FES PET/CT

Interventions

TamoxifenDrug

estrogen modulator

Tamoxifen Dose Levels

FES PET/CTDiagnostic test

Radiolabeled estrogen \[18F\]-fluoroestradiol (FES) in combination with Positron Emission Tomography / Computed Tomography is a molecular imaging technique for measuring pharmacodynamic effects of endocrine therapy. The injected dose of 18F-FES will be 6 mCi (185 MBq) ± 20% with a specific activity greater than 170 Ci/mmol at the time of injection for an activity dose of 6 mCi. Participant will receive baseline imaging and repeat imaging after 3-4 weeks to evaluate for FES blockade as assigned dose level.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participants must have histologically confirmed breast cancer that is metastatic or unresectable with the following:
Estrogen receptor expression by immunohistochemistry greater than or equal to 10%

Sponsors & Collaborators

University of Wisconsin, Madison
Otherlead

Study Sites (2)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

Cancer ConnectCONTACT800-622-8922 clinicaltrials@cancer.wisc.edu

Kari Wisinski, MDPRINCIPAL INVESTIGATOR

Wisconsin Oncology Network (WONIX) sites

Madison, Wisconsin, 53792, United States

NOT_YET_RECRUITING

Cancer ConnectCONTACT

MeSH Terms

Interventions

Tamoxifen

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

Kari Wisinski, MD
University of Wisconsin, Madison
PRINCIPAL INVESTIGATOR

Central Study Contacts

cancer connect

CONTACT

800-622-8922 clinicaltrials@cancer.wisc.edu

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 22, 2019

Study Start

October 20, 2020

Actual (reported)

Primary Completion

December 2026

You may not qualify if:

Prior chemotherapy, radiotherapy, targeted, immunotherapy or investigational therapy within 2 weeks or major surgery within 4 weeks of study enrollment or those who have not recovered (to grade ≤ 1 or baseline) from clinically significant adverse events due to agents administered more than 2 weeks earlier (alopecia and fatigue excluded).
Participants must not be receiving an ER blocking endocrine therapy (includes fulvestrant, tamoxifen, toremifene, raloxifene) and must be off the agents for a minimum of 60 days prior to planned FES PET/CT to allow for adequate uptake of FES.
History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of tamoxifen or \[18F\]-fluoroestradiol.
Peripheral neuropathy of severity greater than grade 1.
Current optic nerve disorders, retinopathy, lattice degeneration, macular degeneration, retinal vascular disorder, or retinal tears of severity greater than grade 1.
History of cerebellar disorders, ataxia, and uncontrolled seizures unless related to transient medical condition and in investigator's opinion is not an active medical issue.
History of venous thrombosis/thromboembolic event, including pulmonary embolism and stroke.
Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 470msec or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, chronic hypokalemia, family history of long QT interval syndrome).
Are taking medications that are known to prolong the QT interval, unless they can be transferred to other medications ≥ 5 half-lives prior to dosing or unless the medications can be properly monitored during the study. If equivalent medication is not available, QTcF should be closely monitored.
Tamoxifen has demonstrated vaginal bleeding, birth defects and fetal loss in pregnant women. Tamoxifen use during pregnancy may have a potential long-term risk to the fetus of a Diethylstilbestrol syndrome (DES)-like syndrome. Women of childbearing potential (WOCP) must not be pregnant (confirmed by a negative urine/serum pregnancy test within 14 days of tamoxifen treatment). In addition, a medically acceptable method of birth control must be used such as an intrauterine device (IUD), use of a double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream), or total abstinence during the study participation and for 3 months after last dose of study drug. Women who are postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) are not considered to be WOCP.
Ongoing treatment with other investigational agents. Participants cannot be receiving concomitant chemotherapy, radiotherapy, experimental therapy or any other therapy not otherwise outlined by the trial for the purposes of anti-cancer treatment.
History of uterine malignancy unless participant has had hysterectomy with no evidence recurrent disease for ≥ 3 years from definitive therapy.
Concurrent malignancy except for the following:
Basal cell or squamous cell skin cancer
In situ cervical cancer
+12 more criteria

FES Imaging to Optimize Tamoxifen for Metastatic Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Tamoxifen Dose Levels

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Tamoxifen Dose Levels

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations