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(Last updated: October 21, 2020)

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NEAREST SITE: 2010 miles
Research Site
Birmingham,AL

VISITS: At least once a month

PHASE: II

NCT ID: NCT04214288

AZD9833 or Fulvestrant For Women With Advanced ER+, HER2- Breast Cancer

SERENA-2: A Randomised, Open-Label, Parallel-Group, Multicentre Phase 2 Study Comparing the Efficacy and Safety of Oral AZD9833 Versus Fulvestrant in Women With Advanced ER-Positive HER2-Negative Breast Cancer Scientific Title

Purpose
To compare the safety and anti-cancer activity of different doses of AZD9833, an experimental anti-estrogen drug that is take by mouth, to fulvestrant (Faslodex®), a commonly used anti-estrogen drug that is given by injection.
Who is this for?
Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. You must not have received more than one chemotherapy and one anti-hormone therapy for advance disease.    Full eligibility criteria
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  • 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">AZD9833, by mouth, daily, ongoing</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, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is an anti-estrogen drug approved to treat postmenopausal women with metastatic, hormone positive (ER+ and/or PR+) breast cancer. </li> <li class="seamTextUnorderedListItem">AZD9833 is an experimental anti-estrogen drug. This means it is only available in a clinical trial.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04214288' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforMetastaticBreastCancer.html' target='_blank'>Susan G. Komen: Recommended Treatments for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/799429' target='_blank'>NCI Drug Dictionary: AZD9833</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fulvestrant' target='_blank'>NCI Drug Dictionary: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Fulvestrant' target='_blank'>Wikipedia: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Selective_estrogen_receptor_degrader' target='_blank'>Wikipedia: Selective Estrogen Receptor Degrader (SERD)</a> </li></ul>
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