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

Recruiting

• Conditions: Metastatic Breast Cancer; Breast Carcinoma; Metastatic Lobular Breast Carcinoma; Metastatic Breast Carcinoma; Breast Cancer; Lobular Breast Carcinoma
• Interventions: Diagnostic Test: 18F-Fluoroestradiol PET/CT

• Registration Number: NCT06557148
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-13
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-08-13
• Study Completion: 2027-08-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC	18F-Fluoroestradiol PET/CT	Participants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

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