Endocrine Therapy + Abemaciclib for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Sarah Sammons, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Duke University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via singe cell RNA sequencing. The investigators will also correlate changes in serum estrogen levels to changes in tumor and peripheral immune cell repertoire and function (including regulatory T cell populations, B cells, myeloid-derived suppressor cell populations, T cell activation and T cell exhaustion).This study has two cohorts with 15 patients in each cohort.

Eligibility Criteria

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.

Inclusion Criteria

My organs are functioning well.

I have a tumor from breast cancer that can be biopsied.

I have fully recovered from any side effects of my recent radiotherapy.

Exclusion Criteria

I do not have serious health issues that would stop me from joining this study.

I am on blood thinners due to a history of blood clots or heart conditions.

I have a bleeding disorder that makes biopsies unsafe for me.

Treatment Details

Interventions

• Abemaciclib (CDK4/6 Inhibitor)
• Aromatase Inhibitors (Hormone Therapy)
• Fulvestrant (Hormone Therapy)

Trial Overview 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.

Participant Groups

Group I: Cohort 1 Active Control 2 Interventions

Fulvestrant plus abemaciclib

Group II: Cohort 2 Active Control 2 Interventions

Aromatase inhibitor plus abemaciclib (with or without ovarian suppression)

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

🇺🇸 Approved in United States as Verzenio for:

• Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

🇪🇺 Approved in European Union as Verzenio for:

• HR+, HER2- advanced or metastatic breast cancer
• HR+, HER2- node-positive early breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Medical Center Durham, NC

Who Is Running the Clinical Trial?

Duke University Lead Sponsor

References