A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer
18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma
1 other identifier
observational
30
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2024
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedStudy Start
First participant enrolled
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 13, 2027
February 27, 2026
February 1, 2026
3 years
August 13, 2024
February 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of FES PET/CT in Metastatic Invasive Lobular Carcinoma/ILC to standard-of-care (SOC) imaging with FDG PET/CT at baseline
Disease detection by 18F-FES and 18F-FDG PET/CT images at baseline will be directly compared
1 year
Study Arms (1)
Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC
Participants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer
Interventions
Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT
Eligibility Criteria
Patients will be recruited from breast medical oncology clinics, with a concerted effort to recruit a diverse group of patients. Recruitment will be led by Co-PI Komal Jhaveri, MD, Assistant Attending, Breast Medicine Service. Eligible patients will be approached to enroll in the protocol and provide written informed consent. Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at MSK. If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (All protocol activity)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Somali Gavane, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 16, 2024
Study Start
August 13, 2024
Primary Completion (Estimated)
August 13, 2027
Study Completion (Estimated)
August 13, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.