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Protocol No. UW19046

Principal Investigator Wisinski, Kari

Phase Pilot/Feasibility

Age Group Adult

Scope National

Sponsor Type Institutional

Title A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients with ESR1 Mutations

Objective We want to find out if using experimental imaging scans (called FES PET/CT scans) can determine the best dose of a drug called tamoxifen in people with advanced estrogen receptor-alpha positive (ER+) breast cancer, who also have a mutation in the gene related to the ER protein

Treatment First, you will have an FES PET/CT scan. If you have a positive FES scan result, you can continue on the study and begin tamoxifen treatment. If your FES scan is negative, you are not able to continue on the study
  • We will test different doses of tamoxifen
  • We will test one dose level at a time until either the highest dose level is reached or unacceptable side effects are experienced. Everyone in this study will get tamoxifen, but the dose level you get will depend on when you enter the study. Tamoxifen is taken once each day by mouth

  • Description A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients with ESR1 Mutations

    Key Eligibility
  • Must have histologically confirmed breast cancer that is metastatic or unresectable with the following: Estrogen receptor expression by immunohistochemistry greater than 10%, ESR1 mutation identified using a CLIA certified assay via tumor biopsy tissue or circulating free DNA (cfDNA), HER2 negative
  • Must have measurable disease as defined by RECIST 1.1 or evaluable bone-only disease with at least one lesion measuring 10 mm or greater in size
  • Must have received at least 1 prior line of non-tamoxifen containing endocrine therapy in the metastatic setting or have had progression within 12 months of adjuvant non-tamoxifen endocrine therapy
  • 18 years of age or older
  • ECOG performance status 0-1
  • Must be able to swallow pills
  • Patients with central nervous system (CNS) metastases must be stable after therapy for CNS metastases (such as surgery, radiation, or stereotactic radiosurgery) for at least 1 month
  • Adequate normal organ and bone marrow function as defined by the protocol
    EXCLUSION
  • Must have received at least 1 prior line of non-tamoxifen containing endocrine therapy in the metastatic setting or have had progression either while taking or within 12 months of adjuvant non-tamoxifen endocrine therapy (i.e. on or within 12 months of an aromatase inhibitor)
  • 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)
  • 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 to allow for adequate uptake of FES
  • 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) greater than or equal to 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)
  • Can not be pregnant or breast feeding
  • History of uterine malignancy unless patient has had hysterectomy with no evidence recurrent disease for greater than or equal to 3 years from definitive therapy
  • Uncontrolled intercurrent clinically significant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics