Title
Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy

Description
This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein with a progestin-based radioligand, 18F-fluorofuranylnorprogesterone (18F-FFNP). The overall purpose of this research is to test the efficacy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy and to determine the quantitative reliability of 18F-FFNP breast PET/MRI in patients with newly diagnosed ER+/PR+/HER2- primary breast cancer.

Objective
Primary Objective

-Determine the diagnostic accuracy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy.

Secondary Objectives

-Determine the repeatability of quantitative assessment of tumor 18F-FFNP uptake.
-Determine the intra- and inter-observer variability of quantitative assessment of tumor 18F-FFNP uptake.
-Assess the safety and tolerability of 18F-FFNP.

Exploratory Objectives

-Define the parent and metabolite fractions of 18F-FFNP over the time course of the scan.
-Assess the association between tumor 18F-FFNP uptake with serum progesterone, estradiol, and corticosteroid binding globulin levels.
-Compare changes in 18F-FFNP breast PET/MRI parameters with changes in PR immunohistochemistry in therapy responders and non-responders.
-Assess the association between tumor 18F-FFNP uptake with disease recurrence.
-Determine whether MRI parameters improve the predictive value of FFNP PET alone.

Treatment Drug: 18F-fluorofuranylnorprogesterone
Device: Positron Emissions Tomography / Magnetic Resonance Imaging
Drug: Anastrozole
Other: Blood Sampling
Drug: Gadobenate dimeglumine

Key Eligibility Inclusion Criteria:

Postmenopausal status defined by either



prior bilateral oophorectomy

age greater than or equal to 60 years of age

age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range



Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality

Biopsy-proven ER-positive, PR-positive, HER2-negative invasive breast cancer

Breast MRI planned or performed before surgery

Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery.

Applicable Disease Sites
Breast

Participating Institutions
UW Health 1 S. Park Medical Center; UW Health Eastpark Medical Center; UW Health University Hospital