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A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
Sponsor: AstraZeneca
Summary
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone receptor-positive (ER-positive), human epidermal growth factor 2-negative (HER2-negative) advanced/metastatic breast cancer. INFORMATION FOR TRIAL PARTICIPANTS In this trial, the researchers will look at how well camizestrant with palbociclib works, compared with anastrozole with palbociclib, in participants with breast cancer that has either spread into other parts of the body at the time of diagnosis, or has come back after at least 2 years of standard endocrine treatment. Participants in this trial will have breast cancer that has ER proteins but does not have overexpression of HER2 protein.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
1370
Start Date
2021-01-28
Completion Date
2029-02-01
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
AZD9833
Dosage formulation: AZD9833 tablets will be administered orally
Anastrozole
Dosage formulation: Anastrozole tablets will be administered orally.
Anastrozole placebo
Dosage formulation: anastrozole placebo tablets will be administrated orally.
AZD9833 placebo
Dosage formulation: AZD9833 placebo tablets will be administrated orally.
Palbociclib
Dosage formulation: palbociclib tablets/capsules 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.
Locations (263)
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Mobile, Alabama, United States
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Springdale, Arkansas, United States
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Harbor City, California, United States
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Solvang, California, 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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