This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast cancer patients with progressive disease on first-line standard-of-care hormonal therapy. All patients will undergo a Cerianna PET/CT scan. The treating physician will complete a standardized questionnaire to indicate the second-line therapeutic management plan before the scheduled Cerianna PET/CT. After interpretation of Cerianna PET/CT by local radiologist or nuclear medicine physician, the treating physician will fill out a similar questionnaire to specify the final therapeutic decision. The proportion of patients with a change in therapeutic management plan based on Cerianna PET/CT results will be the primary endpoint. During the study follow-up period of 18 months, data on standard-of-care imaging, treatments/procedures received, and clinical outcomes will be collected. Patients will be asked to complete a health-related quality of life questionnaire at their screening, 6-month, and 18-month visit. Secondary endpoints include visual and quantitative heterogeneity assessment of tumor Cerianna uptake, and PFS rates at 6 months and 18 months after Cerianna PET/CT, which will be assessed between patients with and without a change in therapeutic management plan. Maximum duration of follow-up for each patient: 20 months. First patient first visit to last patient last visit: estimated 36 months.
Who can participate
Age range
18 Years – 99 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must sign informed consent prior to enrollment in this trial
* The patient is a female ≥18 years old
* Post-menopausal or pre-menopausal patient with known primary breast tumor(s) expressing ER in ≥1% of tumor cells by IHC
* HER2-negative (0, 1+, 2+ fluorescence in situ hybridization (FISH) negative) primary lesion
* MBC with at least 1 identifiable lesion on standard-of-care imaging assessment, outside of the liver, as confirmed by the investigator site
* Patient with progressive disease on 1st line hormonal therapy (Aromatase Inhibitor) with or without a CDK4/6 inhibitor or mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinases (PI3K) inhibitor
* Patient must score at least 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
* Life expectancy of at least 12 months
* The patient is planned to undergo a standard-of-care imaging scan (according to National Comprehensive Cancer Network guidelines, e.g., CT and/or bone scan, or fluorodeoxyglucose \[FDG\]-PET/CT) covering chest, abdomen, and pelvis after date of consent and before Cerianna PET/CT (Visit 2), or the patient has undergone recent standard-of-care imaging before date of consent and is planned to undergo Cerianna PET/CT (Visit 2) no more than 45 days from the standard-of-care imaging scan
Exclusion Criteria:
* Isolated hepatic metastases (taking into account the physiological hepatic high uptake of Cerianna)
* Patient is on tamoxifen/tor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate change in therapeutic management plan assessed by comparing pre/post-Cerianna PET/CT treatment selection (based on comparison of the initial management plan and post-Cerianna PET/CT management plan evaluated within 3 weeks).
Timeframe: [Time Frame: Baseline and within 3 weeks after Cerianna PET/CT