ARV-471 + Abemaciclib for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); and * is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib until their cancer is no longer responding, or side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for individuals with advanced or metastatic breast cancer that's estrogen receptor positive and not responding to previous treatments. Participants must have had up to two prior therapies, including one CDK4/6 inhibitor regimen, and should be in a stable condition without life-threatening visceral complications or recent other cancers.

Inclusion Criteria

I am fully active and can carry on all pre-disease activities without restriction.

At least 1 measurable lesion as defined by RECIST v1.1

My breast cancer is ER+ and HER2-, and cannot be removed by surgery.

See 1 more

Exclusion Criteria

I have had lung problems caused by medication before.

My condition is inflammatory breast cancer.

My kidney, liver, or bone marrow is not working properly.

See 6 more

Treatment Details

Interventions

Abemaciclib (CDK4/6 Inhibitor)
ARV-471 (Estrogen Receptor Degrader)

Trial OverviewThe study tests ARV-471 combined with abemaciclib in people with certain types of breast cancer. Both medications are taken orally at home—ARV-471 once daily and abemaciclib twice daily—and the effects on patients' health will be monitored regularly at the clinic.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ARV-471 in combination with AbemaciclibExperimental Treatment2 Interventions

ARV-471 administered orally once daily (QD) and Abemaciclib orally twice daily (BID) on 28-day cycle