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(Last updated: October 21, 2020)

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NEAREST SITE: 3 miles
UCSF Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03781063

Lasofoxifene or Fulvestrant in Advanced ER+, HER2- Breast Cancer with a ESR1 Mutation

An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation Scientific Title

Purpose
To compare the safety and effects (good and bad) of lasofoxifene (Fablyn®) to fulvestrant (Faslodex®).
Who is this for?
Postmenopausal women with advanced (stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor combined with a CDK 4/6 inhibitor, and have had a cell-free circulating tumor DNA (cDNA) test that shows your tumor has an ESR1 mutation.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene (Fablyn®), by mouth, daily </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fablyn is a nonsteroidal selective estrogen receptor modulator (SERM). </li> <li class="seamTextUnorderedListItem">It has been approved for use in other countries to treat osteoporosis, but is not approved in the U.S. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</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/NCT03781063' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/hormone-therapy/fulvestrant-faslodex' target='_blank'>BreastCancerCare.org.uk: Fulvestrant (Faslodex)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.practiceupdate.com/content/lasofoxifene-vs-fulvestrant-for-hr-positive-breast-cancer/77342' target='_blank'>PracticeUpdate: Lasofoxifene vs Fulvestrant for HR-Positive Breast Cancer</a> </li></ul>
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