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Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Sponsor: AstraZeneca
Summary
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.
Official title: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2021-06-30
Completion Date
2027-11-26
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
AZD9833
Dosage formulation: AZD9833 tablets will be administered orally
AZD9833 Placebo
Dosage formulation: AZD9833 placebo tablets will be administrated orally.
Anastrozole
Dosage formulation: anastrozole tablets will be administered orally.
Anastrozole placebo
Dosage formulation: anastrozole placebo tablets will be administrated orally.
Letrozole
Dosage formulation: letrozole tablets will be administered orally.
Letrozole placebo
Dosage formulation: letrozole placebo tablets will be administered orally.
Palbociclib
Dosage formulation: palbociclib tablets/capsules will be administered orally
Abemaciclib
Dosage formulation: abemaciclib tablets will be administered orally
Luteinizing hormone-releasing hormone (LHRH) agonist
Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
Ribociclib
Dosage formulation: ribociclib tablets will be administered orally
Locations (265)
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Phoenix, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Long Beach, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Grand Junction, Colorado, United States
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Lone Tree, Colorado, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Park Ridge, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Fairhaven, Massachusetts, United States
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Foxborough, Massachusetts, United States
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Milford, Massachusetts, United States
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South Weymouth, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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Oxford, Mississippi, United States
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Kansas City, Missouri, United States
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East Syracuse, New York, United States
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Philadelphia, Pennsylvania, United States
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York, Pennsylvania, United States
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Greenville, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Haskovo, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Lyon, France
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Metz-Tessy, France
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Saint-Herblain, France
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Villejuif, France
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Ansbach, Germany
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Aschaffenburg, Germany
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Bonn, Germany
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Chemnitz, Germany
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Dresden, Germany
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Erlangen, Germany
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Essen, Germany
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Freiburg im Breisgau, Germany
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Cordaleo, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Kayseri, Turkey (Türkiye)
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Sutton, United Kingdom
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Taunton, United Kingdom