A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer

Running, not enrolling

Conditions studied: Breast Cancer, Lobular Breast Carcinoma, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Lobular Breast Carcinoma, Metastatic Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT06557148

Run by

Memorial Sloan Kettering Cancer Center

People needed

7

Starts

2024-08-13

Expected to finish

2027-08-13

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Suffolk-Commack (All protocol activity) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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