Breast Cancer, Breast Carcinoma, Lobular Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, Metastatic Lobular Breast Carcinoma
Conditions
Keywords
breast cancer, lobular breast cancer, lobular breast carcinoma, breast carcinoma, metastatic breast cancer, metastatic lobular breast cancer, metastatic lobular breast carcinoma, metastatic breast carcinoma, 24-134, Memorial Sloan Kettering Cancer Center
Brief summary
The purpose of this study to compare two types of cancer imaging scans to see which is better at detecting and monitoring metastatic ILC. This study will compare PET/CT (positron emission tomography/computed tomography) scans using the radiotracer fluorine 18 (18F)-fluoroestradiol (FES) with a standard imaging approach for detecting and monitoring ILC, PET/CT scans using the radiotracer 18F-fluorodeoxyglucose (FDG). These scans will be referred to as FES PET/CT scans and FDG PET/CT scans.
Interventions
DIAGNOSTIC_TEST18F-Fluoroestradiol PET/CT
Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient \> 18 years old * Biopsy-proven metastatic ILC * Confirmed ER+ breast cancer from either primary tumor or metastatic biopsy (ER receptor percent staining ≥ 10% of tumor cells by IHC) * HER2-negative per ASCO/CAP * ECOG Performance Status Score of 0, 1 or 2. * Patient can have received up to 2 lines of therapy in the metastatic setting * Life expectancy of at least 12 months
Exclusion criteria
* Low ER expression defined as ER \<10% of tumor cells by IHC * Patients who have been on adjuvant ER-blocking endocrine therapy with SERM or SERD without an 8- and 24-weeks washout, respectively. (The use of aromatase inhibitors or ovarian suppression is permitted given that they do not block estrogen receptors). * Pregnancy or lactation 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline | 1 year | Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSomali Gavane, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed