Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
NCT04964934 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315
Last updated 2026-04-21
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.
Conditions
- ER-Positive HER2-Negative Breast Cancer
Interventions
- DRUG
-
Dosage formulation: letrozole tablets will be administered orally.
- DRUG
-
Letrozole placebo
Dosage formulation: letrozole placebo tablets will be administered orally.
- DRUG
-
Dosage formulation: palbociclib tablets/capsules will be administered orally
- DRUG
-
Dosage formulation: abemaciclib tablets will be administered orally
- DRUG
-
Luteinizing hormone-releasing hormone (LHRH) agonist
Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.
- DRUG
-
Dosage formulation: ribociclib tablets will be administered orally
- DRUG
-
AZD9833
Dosage formulation: AZD9833 tablets will be administered orally
- DRUG
-
AZD9833 Placebo
Dosage formulation: AZD9833 placebo tablets will be administrated orally.
- DRUG
-
Anastrozole
Dosage formulation: anastrozole tablets will be administered orally.
- DRUG
-
Anastrozole placebo
Dosage formulation: anastrozole placebo tablets will be administrated orally.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2025-06-30
- Completion
- 2028-09-01
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Bulgaria
- Canada
- France
- Germany
- Hungary
- Israel
- Italy
- Japan
- Norway
- Poland
- Portugal
- Russia
- Slovakia
- South Korea
- Spain
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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