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(Last updated: May 21, 2020)

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NEAREST SITE: 353 miles
City of Hope Comprehensive Cancer

VISITS: Number of visits unavailable


NCT ID: NCT03781063

Lasofoxifene or Fulvestrant in ESR1 positive ER+/HER2- Advanced Breast Cancer

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

To compare the safety and effects (good and bad) of lasofoxifene (Fablyn®) with fulvestrant (Faslodex®).
Who is this for?
Postmenopausal women with estrogen receptor positive, HER2 negative advanced (some stage III) or metastatic (stage IV) breast cancer who has been treated with an aromatase inhibitor combined with a cyclin dependent kinase (CDK) 4/6 inhibitor, and has had a cell-free circulating tumor DNA (cDNA) test that shows your tumor has an ESR1 mutation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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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