Investigating a new imaging method for breast cancer treatment response
Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
This study is testing a new imaging method to see if it can help predict how well women with a certain type of breast cancer respond to hormone therapy before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06086704 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of 18F-FFNP PET/MRI in predicting how well patients with progesterone receptor-positive breast cancer respond to presurgical endocrine therapy. The study will assess the diagnostic accuracy of this imaging technique, as well as its repeatability and variability in measuring tumor uptake of the radioligand. Additionally, it will explore the relationship between imaging results and hormone levels, and how these correlate with treatment outcomes. The trial will also monitor the safety and tolerability of the imaging agent used.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women with biopsy-proven invasive breast cancer that is at least 1.0 cm in diameter and is progesterone receptor-positive.
Not a fit: Patients with HER2-positive breast cancer or those who are unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for predicting treatment responses in breast cancer patients, potentially leading to more personalized and effective treatment plans.
How similar studies have performed: Other studies have shown promise in using imaging techniques to assess treatment responses in breast cancer, but this specific approach with 18F-FFNP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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 * Biopsy-proven PR-positive 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. 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 * 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 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 * Patients taking hormone replacement therapy or over-the-counter products/supplements/herbal preparation with potential estrogenic effects who are unwilling to discontinue these agents during the timeframe of the study until surgery.
Where this trial is running
Madison, Wisconsin
- UW Carbone Cancer Center — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Amy M Fowler, MD, PHD — UW Carbone Cancer Center
- Study coordinator: Cancer Connect
- Email: clinicaltrials@cancer.wisc.edu
- Phone: 800-622-8922
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.