Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 22, 2024

Primary Completion Date

March 1, 2027

Study Completion Date

June 1, 2028

Conditions
Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Locally Advanced Unresectable HER2-Negative Breast CarcinomaLocally Advanced Unresectable Hormone Receptor-Positive Breast CarcinomaMetastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast Carcinoma
Interventions
DRUG

Abemaciclib

Given PO

DRUG

Anastrozole

Given PO

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Diagnostic Imaging Testing

Undergo clinical imaging for tumor assessment

DRUG

Exemestane

Given PO

OTHER

Fludeoxyglucose F-18

Given IV

DRUG

Fluorine F 18 Fluoro Furanyl Norprogesterone

Given IV

DRUG

Fulvestrant

Given IM injection

BIOLOGICAL

Gonadotropin-releasing Hormone Analog

Given GnRH analog

DRUG

Letrozole

Given PO

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Tamoxifen

Given PO

DRUG

Therapeutic Estradiol

Given PO

Trial Locations (2)

63110

RECRUITING

Siteman Cancer Center at Washington University, St Louis

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

Sponsors
All Listed Sponsors
collaborator

Breast Cancer Research Foundation

OTHER

lead

University of Washington

OTHER