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 (NCT04711252)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Research Site โ Mobile, Alabama
Age range: 18 Years to 130 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (263 Sites)
Showing the first 25 of 263 sites.
- Research Site โ Mobile, Alabama
- Research Site โ Springdale, Arkansas
- Research Site โ Harbor City, California
- Research Site โ Solvang, California
- Research Site โ Lone Tree, Colorado
- Research Site โ Fort Myers, Florida
- Research Site โ Jacksonville, Florida
- Research Site โ West Palm Beach, Florida
- Research Site โ Indianapolis, Indiana
- Research Site โ Baton Rouge, Louisiana
- Research Site โ Silver Spring, Maryland
- Research Site โ Boston, Massachusetts
- Research Site โ Detroit, Michigan
- Research Site โ Hattiesburg, Mississippi
- Research Site โ Omaha, Nebraska
- Research Site โ Cincinnati, Ohio
- Research Site โ Cincinnati, Ohio
- Research Site โ Portland, Oregon
- Research Site โ West Columbia, South Carolina
- Research Site โ Sioux Falls, South Dakota
- Research Site โ Chattanooga, Tennessee
- Research Site โ Nashville, Tennessee
- Research Site โ Austin, Texas
- Research Site โ Houston, Texas
- Research Site โ Houston, Texas
๐ฐ 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 ยง 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.
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๐ก 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.