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
NCT04711252 · SERENA-4 Phase 3Active, not recruiting
- Lead sponsor
- AstraZeneca (Industry)
- Enrollment
- 1,371 (actual)
- Start date
- 28 Jan 2021
- Primary completion
- 26 Jun 2026 (actual)
- Study completion
- 1 Feb 2029
- Last update posted
- 28 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Triple
- Arms
- 2
Interventions
- AZD9833 Drug
- Anastrozole Drug
- Anastrozole placebo Drug
- AZD9833 placebo Drug
- Palbociclib Drug
- Luteinizing hormone-releasing hormone (LHRH) agonist Drug
Conditions and primary outcome
- ER-Positive HER2-Negative Breast Cancer
Primary outcome
Progression-free survival (PFS) assessed by the Investigator as defined by response evaluation criteria in solid tumors (RECIST) version 1.1 (From randomization until progression per RECIST 1.1 as assessed by the investigator at local site or death due to any cause (up to 5 years))
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT04711252.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04711252 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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