Elacestrant vs Elacestrant + CDK4/6 Inhibitor for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by William Gradishar, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting. The purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.

Eligibility Criteria

This trial is for adults with ER+/HER2- advanced or metastatic breast cancer who have tried at least two endocrine therapies, including a CDK4/6 inhibitor. They should be in good physical condition (ECOG 0 or 1), have no severe heart issues, and not be at immediate risk due to visceral spread. Participants must not have had recent chemotherapy, major surgery, or certain other treatments.

Inclusion Criteria

My cancer has a confirmed ESR1 mutation.

I have at least one tumor that can be measured or a mainly lytic bone lesion.

I have had at least 2 hormone treatments for my cancer, including a CDK4/6 inhibitor.

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 28 days.

I do not have any uncontrolled illnesses.

My advanced cancer is causing symptoms and could lead to serious complications soon.

Participant Groups

The study tests if elacestrant's effectiveness improves when combined with a CDK4/6 inhibitor (palbociclib, abemaciclib, ribociclib) in patients previously treated with a CDK4/6 inhibitor. It aims to overcome resistance often seen in this common subtype of breast cancer after standard treatment.

Group I: Elacestrant Monotherapy Experimental Treatment 1 Intervention

Elacestrant (345 mg) will be taken orally once daily for each 28-day cycle. Courses repeat until progressive disease.

Group II: Combination Therapy Experimental Treatment 1 Intervention

Patients will receive either: Elacestrant 345 mg orally once daily + Palbociclib 125 mg orally once daily for 21 days out of 28-day cycle OR Abemaciclib 150 mg orally twice daily OR Ribociclib 600 mg orally once daily for 21 days out of 28-day cycle

Elacestrant is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Orserdu for:

• ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

🇪🇺 Approved in European Union as Orserdu for:

• ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwestern University Chicago, IL

Who Is Running the Clinical Trial?

Northwestern University Lead Sponsor

National Cancer Institute (NCI) Collaborator

References