No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
53 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for postmenopausal women with invasive breast cancer. Participants will take part in imaging tests to see how their cancer responds to treatment before surgery.
Are You a Good Fit for This Trial?
Rules you outLiver failure
You may be able to join if
I am postmenopausal
I have been diagnosed with invasive breast cancer at least 1 cm in size
I have biopsy-proven PR-positive breast cancer
I am planning definitive surgery without other treatments before surgery
You may not be able to join if
I cannot provide consent for the study
I have HER2-positive breast cancer
I have taken certain therapies for my breast cancer before joining the study
I am currently taking aromatase inhibitors or ER antagonists
I am pregnant or breastfeeding
I have allergies to gadolinium-based contrast agents
I have a history of allergic reactions to similar compounds
I require sedation for imaging
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 quant…
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 PR+ primary breast cancer.
Trial Locations
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Status
Eligibility Criteria
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…
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 (Group 2 only)
* Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality. Malignancy may be located within the breast, axilla (e.g. metastatic axillary lymph node), or both the breast and axilla
* Biopsy-proven PR-positive invasive breast cancer
* 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. (Group 2 only)
Exclusion Criteria:
* Inability or unwillingness to provide informed consent to the study
* HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only)
* PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available
* Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy (Group 2 only)
* Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
* Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene)
* Patients with breast expanders
* Patients who are pregnant or lactating
* Patients with clinical contraindication for use of aromatase inhibitors (AI) while on study as determined by investigator (Group 2 only)
* Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines)
* Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP
* Patients with history of allergic reaction to anastrozole (Group 2 only)
* Patients in liver failure as judged by the patient's physician
* Patients with standard contraindications to MRI (per UW Health Guidelines)
* Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
* The patient has their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of the medication.
* The patient comes to the research visit with a driver.
* Patients unable to lie prone for 45 minutes for imaging
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