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(Last updated: November 29, 2020)

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NEAREST SITE: 903 miles
St. Vincent Frontier Cancer Center
Billings,MT

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04576455

The Experimental Anti-Estrogen Therapy GDC-9545 for Advanced ER+, HER2- Breast Cancer

A Phase II, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Compared With Physician's Choice of Endocrine Monotherapy in Patients With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose
To compare the safety and anti-cancer activity of the experimental anti-estrogen therapy GDC-9545 to currently approved anti-hormone therapies.
Who is this for?
People with locally advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have already received one or two therapies for advanced or metastatic 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 and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-9545, by mouth, daily ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Your doctor's choice of anti-hormone therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) or an aromatase inhibitor</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-9545 is an experimental anti-estrogen therapy.</li> <li class="seamTextUnorderedListItem">Anti-estrogen therapies currently approved to treat advanced breast cancer include fulvestrant (Faslodex®) and the aromatase inhibitors: anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04576455' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/giredestrant' target='_blank'>NCI Drug Dictionary: GDC-9545</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet' target='_blank'>NCI: Hormone Therapy for Breast Cancer</a> </li></ul>
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