Endocrine Therapy + Abemaciclib for Breast Cancer

Phase 2

Waitlist Available

Led By Sarah Sammons, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of a new cancer drug on the tumor and the patient's immune system.

Who is the study for?

This trial is for women over 18 with advanced ER+/HER2- breast cancer who can swallow pills, have good organ function, and can undergo biopsies. They should not be using hormonal birth control or have active cancers (except certain skin cancers), autoimmune diseases, serious infections, or conditions that make biopsy unsafe.

What is being tested?

The study tests how standard endocrine therapy plus abemaciclib affects immune cells in the tumor environment of breast cancer patients. It involves detailed analysis through single cell RNA sequencing and monitoring changes related to serum estrogen levels.

What are the potential side effects?

Potential side effects include reactions from biopsies, fatigue from treatment, possible digestive issues due to oral medications, and risks associated with changes in immune cell functions which could affect overall immunity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in serum estrogen (E1 and E2) levels compared to changes in tumor immune cell repertoire and function in response to endocrine therapy and CDK 4/6 inhibition

Changes in serum estrogen (E1 and E2) levels compared to peripheral blood mononuclear cell repertoire and function in response to endocrine therapy and CDK 4/6 inhibition

Secondary study objectives

Best overall response rate of abemaciclib and endocrine therapy in both treatment arms

Changes in tumor immune cell populations in response to fulvestrant and aromatase inhibitor therapy plus abemaciclib, measured by sequential biopsies

Biopsy

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