clinical utility of fes f18 pet/ct in metastatic breast cancer patients

Conditions: Metastatic Breast Cancer

Summary: 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.


Eligibility criteria:
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/toremifene treatment without 8-week washout, or on fulvestrant treatment without 28-week washout, (may block er) before cerianna pet/ct * other evolutive malignant disease (non-melanoma skin cancer is allowed) or acute or chronic infectious disease (well-controlled infectious disease is allowed); * patient has a history of administered chemotherapy for metastatic disease; prior chemotherapy in the (neo)adjuvant setting is allowed * patient with a known allergy to any of the components of cerianna * woman of childbearing age who is not using effective contraception * pregnant woman (per the product label and ensured using clinic's standard-of-care), or parturient or nursing mother * patient presents with any other clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who has a life expectancy of \<12 months, or for whom study participation may compromise their management; and/or a patient who the investigator judges to be unsuitable for participation in the study for any reason * inability to comply with any requirements of the protocol

Keywords: metastatic breast cancer pet/ct cerianna fes fluoroestradiol f-18