RECRUITING

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

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Conditions

Breast CancerLobular Breast CarcinomaBreast CarcinomaMetastatic Breast CancerMetastatic Lobular Breast CarcinomaMetastatic Breast Carcinomalobular breast cancermetastatic lobular breast cancer24-134Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

18F-Fluoroestradiol (FES) Positron Emission Tomography for the Detection and Treatment Response Monitoring in Patients With Metastatic Lobular Breast Carcinoma

Quick Facts

Study Start:2024-08-13
Study Completion:2027-08-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06557148

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patient \> 18 years old
  2. * Biopsy-proven metastatic ILC
  3. * Confirmed ER+ breast cancer from either primary tumor or metastatic biopsy (ER receptor percent staining ≥ 10% of tumor cells by IHC)
  4. * HER2-negative per ASCO/CAP
  5. * ECOG Performance Status Score of 0, 1 or 2.
  6. * Patient can have received up to 2 lines of therapy in the metastatic setting
  7. * Life expectancy of at least 12 months
  1. * Low ER expression defined as ER \<10% of tumor cells by IHC
  2. * 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).
  3. * Pregnancy or lactation or parturient or nursing mother
  4. * 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.

Contacts and Locations

Study Contact

Randy Yeh, MD
CONTACT
2126393776
yehr@mskcc.org
Komal Jhaveri, MD
CONTACT
646-888-5145
jhaverik@mskcc.org

Principal Investigator

Randy Yeh, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Randy Yeh, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13
Study Completion Date2027-08-13

Study Record Updates

Study Start Date2024-08-13
Study Completion Date2027-08-13

Terms related to this study

Keywords Provided by Researchers

  • 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

Additional Relevant MeSH Terms

  • Breast Cancer
  • Lobular Breast Carcinoma
  • Breast Carcinoma
  • Metastatic Breast Cancer
  • Metastatic Lobular Breast Carcinoma
  • Metastatic Breast Carcinoma