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(Last updated: October 24, 2020)

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1

NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI

VISITS: 1 visit every 3 to 4 weeks, ongoing

PHASE: NA

NCT ID: NCT04174352

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation

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

Purpose
To study if FES-PET/CT scans can help find a personalized dose of tamoxifen (Nolvadex®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that tests positive for a ESR1 mutation.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">FES PET/CT scan, every 3 to 4 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">ESR1 mutations in breast cancer may affect how well tamoxifen works against tumor cells. </li> <li class="seamTextUnorderedListItem">Tracers are chemicals that are used to find cancer cells in the body during a PET scan. The imaging trial will use the tracer fluoroestradiol (FES)--it finds estrogen receptors in breast tumors. </li> <li class="seamTextUnorderedListItem">The FES tracer may also show how tamoxifen is affecting your tumors. Researchers may use this information to increase your dose of tamoxifen.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04174352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/hormonal-therapy-metastatic-breast-cancer' target='_blank'>ASCO Cancer.net: Hormonal Therapy for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/more-effective-therapies-needed-for-patients-with-esr1mutated-breast-cancer' target='_blank'>Targeted Oncology: More Effective Therapies Needed For Patients With ESR1-Mutated Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.karger.com/Article/FullText/481428' target='_blank'>Journal Article: Are We Ready to Use ESR1 Mutations in Clinical Practice</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ijcem.com/files/ijcem0076055.pdf' target='_blank'>Journal Article: The Role of PET Imaging Probes for Early Monitoring the Response to Tamoxifen</a> </li></ul>
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