A Study Comparing Cancer Imaging Approaches in People With Lobular Breast Cancer
NCT ID: NCT06557148
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-08-13
2027-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Biopsy-proven ER+ Metastatic Invasive Lobular Carcinoma/ILC
Participants will have biopsy-proven metastatic ILC, confirmed ER+ breast cancer
18F-Fluoroestradiol PET/CT
Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT
Interventions
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18F-Fluoroestradiol PET/CT
Scanned at baseline and again posttreatment within 2 weeks of the restaging FDG PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Somali Gavane, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Somali Gavane, MD
Role: primary
Somali Gavane, MD
Role: primary
Somali Gavane, MD
Role: primary
Somali Gavane, MD
Role: primary
Somali Gavane, MD
Role: primary
Somali Gavane, MD
Role: primary
Somali Gavane, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-134
Identifier Type: -
Identifier Source: org_study_id
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