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(Last updated: September 10, 2021)

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NEAREST SITE: 671 miles
Research Site
Renton,WA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04711252

CDK4/6 Inhibitor Palbociclib with AZD9833 or an Aromatase Inhibitor for Metastatic, ER+, HER2- Breast Cancer

SERENA-4: A Randomised, Multicentre, Double-Blind, Phase III Study of AZD9833 (an Oral SERD) Plus Palbociclib Versus Anastrozole Plus Palbociclib for the Treatment of Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease Scientific Title

Purpose
To compare the anti-cancer activity of using the experimental anti-estrogen therapy AZD9833 to the aromatase inhibitor anastrazole (Arimidex®) when giving in combination with a CDK 4/6 inhibitor.
Who is this for?
People with metastatic (stage IV), estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer who have not already received a CDK 4/6 inhibitor.    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">AZD9833, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for anastrozole (Arimidex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for AZD9833, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9833 is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degraded).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Fulvestrant is given by injection.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is a type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early-stage and metastatic hormone-positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with approved anti-estrogen therapies for metastatic HR+, HER2- breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/new-strategies-shift-landscape-in-hr-metastatic-breast-cancer' target='_blank'>OncLive: New Strategies Shift Landscape in HR+ Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.1024' target='_blank'>ASCO Abstract: Next Generation Oral SERD AZD9833 in Women with ER-Positive, HER2-Negative Advanced Breast Cancer</a> </li></ul>
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