Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (NCT04964934)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Research Site — Phoenix, Arizona
Age range: 18 Years to 130 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (264 Sites)
Showing the first 25 of 264 sites.
- Research Site — Phoenix, Arizona
- Research Site — Hot Springs, Arkansas
- Research Site — Little Rock, Arkansas
- Research Site — Long Beach, California
- Research Site — San Diego, California
- Research Site — Santa Rosa, California
- Research Site — Grand Junction, Colorado
- Research Site — Lone Tree, Colorado
- Research Site — Fort Myers, Florida
- Research Site — Jacksonville, Florida
- Research Site — Jacksonville, Florida
- Research Site — St. Petersburg, Florida
- Research Site — Atlanta, Georgia
- Research Site — Atlanta, Georgia
- Research Site — Atlanta, Georgia
- Research Site — Park Ridge, Illinois
- Research Site — Fort Wayne, Indiana
- Research Site — Indianapolis, Indiana
- Research Site — Baltimore, Maryland
- Research Site — Boston, Massachusetts
- Research Site — Fairhaven, Massachusetts
- Research Site — Foxborough, Massachusetts
- Research Site — Milford, Massachusetts
- Research Site — South Weymouth, Massachusetts
- Research Site — Detroit, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in ER-Positive HER2-Negative Breast Cancer
- 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 — Mobile, Alabama
- A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer — Duarte, California
Explore by condition: All ER-Positive HER2-Negative Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.