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(Last updated: September 10, 2021)

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NEAREST SITE: 1761 miles
University of Wisconsin Carbone Cancer Center
Madison,WI

VISITS: 1 visit a month

PHASE: II

NCT ID: NCT04738292

Two Anti-Hormone Therapies for Advanced ER+, HER2- Breast Cancer

A Phase II Trial of OnapriStone in CoMbInation With FuLvestrant for Patients With ER-positive, and HER2-negative Metastatic Breast Cancer After Progression on Endocrine Therapy and CDK 4/6 Inhibitors Scientific Title

Purpose
To study the anti-cancer activity and side effects of giving an anti-estrogen therapy along with an anti-progesterone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2 negative (HER2-) breast cancer who have already received an anti-hormone therapy and a CDK 4/6 inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Onapristone (ONA-XR), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month (twice the first month), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONA-XR is an experimental anti-progesterone therapy.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader). It is approved to treat some people with advanced HR+ breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04738292' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.contexttherapeutics.com/pipeline-onapristone' target='_blank'>Context Therapeutics Drug Information Page: Onapristone (ONA-XR)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a607031.html' target='_blank'>MedLinePlus: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/bjc2016303' target='_blank'>Journal Article: Renewed Interest in the Progesterone Receptor in Breast Cancer</a> </li></ul>
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