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NCT04964934 · ClinicalTrials.gov registry record · Phase 3
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
A Phase 3 study of ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT04964934: Active Phase 3 study of ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.
NCT04964934 is a Phase 3 study of ER-Positive HER2-Negative Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 315 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04964934, a Phase 3 study of ER-Positive HER2-Negative Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST 1.1) or death.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG AZD9833
- DRUG AZD9833 Placebo
- DRUG Anastrozole placebo
Study Locations (20)
Florida
- Research Site - Fort Myers
- Research Site - Jacksonville
- Research Site - Jacksonville
- Research Site - St. Petersburg
California
- Research Site - Long Beach
- Research Site - San Diego
- Research Site - Santa Rosa
Georgia
- Research Site - Atlanta
- Research Site - Atlanta
- Research Site - Atlanta
Arkansas
- Research Site - Hot Springs
- Research Site - Little Rock
Colorado
- Research Site - Grand Junction
- Research Site - Lone Tree
Indiana
- Research Site - Fort Wayne
- Research Site - Indianapolis
Arizona
- Research Site - Phoenix
Illinois
- Research Site - Park Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2027-11-26 |
| Phase | Phase 3 |
What the registry record for NCT04964934 still lists
NCT04964934 is an interventional study that assigns participants to a tested intervention. The registered 315 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 1 condition, with ER-Positive HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Anastrozole is the first listed.
NCT04964934 names 20 study sites across 10 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04964934 about?
NCT04964934 is a clinical study titled "Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)". 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 gro...
What is the current status of trial NCT04964934?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 315 participants. The study started on 2021-06-30. Estimated completion is 2027-11-26.
What conditions does trial NCT04964934 study?
This clinical trial studies the following conditions: ER-Positive HER2-Negative Breast Cancer.
What interventions are being tested in trial NCT04964934?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), AZD9833 (DRUG), AZD9833 Placebo (DRUG), Anastrozole placebo (DRUG).
Who is sponsoring clinical trial NCT04964934?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04964934 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for ER-Positive HER2-Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04964934's enrollment target sits among peer trials
315 1093rd of 2000 higher than 905 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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