Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
Public ClinicalTrials.gov record NCT04964934. 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
A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromatase Inhibitor+ CDK4/6 Inhibitor- A ctDNA Guided Early Switch Study
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 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.
Study identification
- NCT ID
- NCT04964934
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 315 participants
Conditions and interventions
Conditions
Interventions
- AZD9833 Drug
- AZD9833 Placebo Drug
- Anastrozole Drug
- Anastrozole placebo Drug
- Letrozole Drug
- Letrozole placebo Drug
- Palbociclib Drug
- Abemaciclib Drug
- Luteinizing hormone-releasing hormone (LHRH) agonist Drug
- Ribociclib 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
- Jun 30, 2021 (Actual)
- Primary completion
- Jun 30, 2025 (Actual)
- Completion
- Sep 1, 2028 (Estimated)
- Last update posted
- Sep 23, 2026
2021 – 2028
United States locations
- U.S. sites
- 64
- U.S. states
- 29
- U.S. cities
- 59
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85054 | — |
| Research Site | Hot Springs | Arkansas | 71913 | — |
| Research Site | Little Rock | Arkansas | 72205 | — |
| Research Site | Long Beach | California | 90806 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | Santa Rosa | California | 92805 | — |
| Research Site | Grand Junction | Colorado | 81501 | — |
| Research Site | Lone Tree | Colorado | 80124 | — |
| Research Site | Fort Myers | Florida | 33901 | — |
| Research Site | Jacksonville | Florida | 32224 | — |
| Research Site | Jacksonville | Florida | 32256 | — |
| Research Site | St. Petersburg | Florida | 33705 | — |
| Research Site | Atlanta | Georgia | 30318 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Atlanta | Georgia | 30342 | — |
| Research Site | Park Ridge | Illinois | 60068 | — |
| Research Site | Fort Wayne | Indiana | 46804 | — |
| Research Site | Indianapolis | Indiana | 46250 | — |
| Research Site | Baltimore | Maryland | 21202 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Fairhaven | Massachusetts | 02719 | — |
| Research Site | Foxborough | Massachusetts | 02035 | — |
| Research Site | Milford | Massachusetts | 01757 | — |
| Research Site | South Weymouth | Massachusetts | 02190 | — |
| Research Site | Detroit | Michigan | 48202 | — |
| Research Site | Grand Rapids | Michigan | 49503 | — |
| Research Site | Rochester | Minnesota | 55905 | — |
| Research Site | Oxford | Mississippi | 38655 | — |
| Research Site | Kansas City | Missouri | 64111 | — |
| Research Site | St Louis | Missouri | 63110 | — |
| Research Site | Billings | Montana | 59101 | — |
| Research Site | Omaha | Nebraska | 68130 | — |
| Research Site | Camden | New Jersey | 08103 | — |
| Research Site | Ridgewood | New Jersey | 07450 | — |
| Research Site | Brooklyn | New York | 11215 | — |
| Research Site | East Syracuse | New York | 13057 | — |
| Research Site | New Hyde Park | New York | 11042 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | New York | New York | 11355 | — |
| Research Site | Shirley | New York | 11967 | — |
| Research Site | Goldsboro | North Carolina | 27534 | — |
| Research Site | Canton | Ohio | 44710 | — |
| Research Site | Cincinnati | Ohio | 45220 | — |
| Research Site | Columbus | Ohio | 43219 | — |
| Research Site | Portland | Oregon | 97213 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | York | Pennsylvania | 17403 | — |
| Research Site | Greenville | South Carolina | 29607 | — |
| Research Site | West Columbia | South Carolina | 29169 | — |
| Research Site | Knoxville | Tennessee | 37916 | — |
| Research Site | Memphis | Tennessee | 38120 | — |
| Research Site | Nashville | Tennessee | 37203 | — |
| Research Site | Bedford | Texas | 76022 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | Houston | Texas | 77024 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Longview | Texas | 75601 | — |
| Research Site | San Antonio | Texas | 78240 | — |
| Research Site | Salt Lake City | Utah | 84106 | — |
| Research Site | Midlothian | Virginia | 23114 | — |
| Research Site | Norfolk | Virginia | 23502 | — |
| Research Site | Tacoma | Washington | 98405 | — |
| Research Site | Waukesha | Wisconsin | 53226 | — |
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 200 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04964934, 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 23, 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 NCT04964934 live on ClinicalTrials.gov.