OHSU Knight Cancer Institute

IRB #

STUDY00021243

Title

OHSU IIT: A Phase 1 Study of Abemaciclib and Niraparib as Neoadjuvant Therapy in Hormone Receptor Positive (HR+) HER2 Negative (HER2-) Breast Cancer

Principal Investigator

Evie Hobbs

Study Purpose

The purpose of this study is to assess the safety and tolerability of the combination of abemacicilib and niraparib in early-stage hormone receptor-positive breast cancer.

We also want to learn more about how participants' tumors respond to this treatment by performing clinical tests on biopsied tumor tissue.

Medical Condition(s)

Hormone Receptor-positive, HER2-negative Breast Cancer

Eligibility Criteria

Females 18 years and older
Biopsy proven HR-positive breast cancer
Must be able to undergo biopsy
No prior PARP or CDK 4/6 inhibitor exposure

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drugs for up to 16 weeks (112 days) before going to surgery. After surgery, the investigator 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 for 5 years or until the study has been completed.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

OHSU Knight Cancer Institute

Recruitment End

11/30/2030

Compensation Provided

No