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

Summary

This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide.

Conditions

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Locally Advanced Unresectable HER2-Negative Breast Carcinoma
• Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
• Metastatic HER2-Negative Breast Carcinoma
• Metastatic 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

Sponsors & Collaborators

• Breast Cancer Research Foundation

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Hannah Linden · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-22

Primary Completion

2027-03-01

Completion

2028-06-01

FDA Drug

Yes

Countries

• United States

Study Locations