IRB #

STUDY00019358

Title

Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)

Principal Investigator

Zahi Mitri

Study Purpose

The purpose of this study is to find out if an investigational drug called elacestrant, also known as RAD1901, can help people with estrogen receptor (ER) positive advanced breast cancer. This study will be comparing the safety and effectiveness of elacestrant to a selection of medications that are already approved and used to treat ER positive advanced breast cancer. It is not known whether the investigational drug elacestrant is better or worse compared to these selected medications, or to other treatments that might be given to treat ER+ advanced breast cancer that are not being tested in this study.

Medical Condition(s)

Advanced/metastatic estrogen receptor positive/ human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer

Eligibility Criteria

Female or male 18 years old or older

Men or postmenopausal women with confirmed ER-positive, HER2- negative advanced or metastatic breast cancer

Previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer

Must have received prior treatement with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug or the standard of care (SoC) treatment for as long as your cancer does not get worse or you do not have bad side effects. After you finish treatment, the investigator and/or study team will continue to watch you for side effects and follow your condition either with follow-up clinic visits or follow-up phone calls every 8 weeks until study completion.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
knight@ohsu.edu

Sponsor

Radius Pharmaceuticals, Inc.

Recruitment End

12/31/2030

Compensation Provided

No


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