IRB #

STUDY00022730

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

Principal Investigator

Eric Anderson

Study Purpose

The study is intended to show how safe and effective the combination of AZD9833 with palbociclib is in treating advanced/metastatic breast cancer compared to the alternative standard of care treatment (anastrozole in combination with palbociclib).

Medical Condition(s)

ER-positive, HER2-negative Advanced/Metastatic Breast Cancer

Eligibility Criteria

18 years or older
ER-positive, HER2-negative breast cancer
Previously untreated with any systemic anti-cancer therapy for locoregionally recurrent or metastatic ER+ disease

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drugs for as long as your cancer does not get worse or you do not have bad side effects. After you are done getting treated with the study drugs, we may contact you every 12 weeks until the study closes to see how you are doing and to ask about your cancer.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

AstraZeneca

Recruitment End

03/31/2031

Compensation Provided

No


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