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NCT04711252 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 1,370
- Enrollment target
- 20
- Study locations
NCT04711252: Active Phase 3 study of ER-Positive HER2-Negative Breast Cancer, sponsored by AstraZeneca.
NCT04711252 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 1,370 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04711252, 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
- 1,370 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
PFS is defined as the time from randomization to objective disease progression (as assessed by RECIST) or death.
Conditions Studied
Interventions
- DRUG Anastrozole
- DRUG Palbociclib
- DRUG AZD9833
- DRUG Anastrozole placebo
- DRUG AZD9833 placebo
Study Locations (20)
Florida
- Research Site - Fort Myers
- Research Site - Jacksonville
- Research Site - West Palm Beach
California
- Research Site - Harbor City
- Research Site - Solvang
Ohio
- Research Site - Cincinnati
- Research Site - Cincinnati
Alabama
- Research Site - Mobile
Arkansas
- Research Site - Springdale
Colorado
- Research Site - Lone Tree
Indiana
- Research Site - Indianapolis
Louisiana
- Research Site - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,370 participants |
| Start Date | 2021-01-28 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 3 |
What the registry record for NCT04711252 still lists
NCT04711252 is an interventional study that assigns participants to a tested intervention. Its 1,370 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% higher).
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.
NCT04711252 names 20 study sites across 16 states, led by Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT04711252 about?
NCT04711252 is a clinical study titled "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". 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-nega...
What is the current status of trial NCT04711252?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,370 participants. The study started on 2021-01-28. Estimated completion is 2029-02-01.
What conditions does trial NCT04711252 study?
This clinical trial studies the following conditions: ER-Positive HER2-Negative Breast Cancer.
What interventions are being tested in trial NCT04711252?
The interventions under investigation include: Anastrozole (DRUG), Palbociclib (DRUG), AZD9833 (DRUG), Anastrozole placebo (DRUG), AZD9833 placebo (DRUG).
Who is sponsoring clinical trial NCT04711252?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04711252 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04711252's enrollment target sits among peer trials
1,370 177th of 2000 higher than 1,823 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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