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
Public ClinicalTrials.gov record NCT04711252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04711252
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,371 participants
Conditions and interventions
Conditions
Interventions
- AZD9833 Drug
- Anastrozole Drug
- Anastrozole placebo Drug
- AZD9833 placebo Drug
- Palbociclib Drug
- Luteinizing hormone-releasing hormone (LHRH) agonist Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 28, 2021 (Actual)
- Primary completion
- Jun 26, 2026 (Actual)
- Completion
- Feb 1, 2029 (Estimated)
- Last update posted
- Sep 28, 2026
2021 – 2029
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Mobile | Alabama | 36604 | — |
| Research Site | Springdale | Arkansas | 72762 | — |
| Research Site | Harbor City | California | 90710 | — |
| Research Site | Solvang | California | 93463 | — |
| Research Site | Lone Tree | Colorado | 80124 | — |
| Research Site | Fort Myers | Florida | 33901-8101 | — |
| Research Site | Jacksonville | Florida | 32256 | — |
| Research Site | West Palm Beach | Florida | 33401 | — |
| Research Site | Indianapolis | Indiana | 46256 | — |
| Research Site | Baton Rouge | Louisiana | 70809 | — |
| Research Site | Silver Spring | Maryland | 20904 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Detroit | Michigan | 48202 | — |
| Research Site | Hattiesburg | Mississippi | 39401 | — |
| Research Site | Omaha | Nebraska | 68130 | — |
| Research Site | Cincinnati | Ohio | 45219 | — |
| Research Site | Cincinnati | Ohio | 45267 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | West Columbia | South Carolina | 29169 | — |
| Research Site | Sioux Falls | South Dakota | 57105 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Austin | Texas | 78731 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Houston | Texas | 77090 | — |
| Research Site | Tyler | Texas | 75702 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Kennewick | Washington | 99336 | — |
| Research Site | Renton | Washington | 98055 | — |
| Research Site | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 233 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04711252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04711252 live on ClinicalTrials.gov.