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NCT02398773 · ClinicalTrials.gov registry record · Phase 2
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
A Phase 2 study of HER2/Neu Negative and Progesterone Receptor Negative, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 20
- Study locations
NCT02398773: Active Phase 2 study of HER2/Neu Negative and Progesterone Receptor Negative, sponsored by National Cancer Institute (NCI).
NCT02398773 is a Phase 2 study of HER2/Neu Negative and Progesterone Receptor Negative that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 99 participants, below the 164-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02398773, a Phase 2 study of HER2/Neu Negative and Progesterone Receptor Negative, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may "light up" where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.
Primary Outcome
FES-PET results will be assessed as positive or negative by quantitative or qualitative criteria. FES SUVmax \< 1.5 will be defined as quantitatively negative test result while one or more sites of active disease will be qualitatively negative test result. The reference standard is patient's tumor response categorized by either CB or PD at 6 months. As part of the preliminary analysis, rates of FES uptake negative results overall and next by tumor response status will be calculated. FES-PET test
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Laboratory Biomarker Analysis
- DRUG F-18 16 Alpha-Fluoroestradiol
Study Locations (20)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
Indiana
- Indiana University/Melvin and Bren Simon Cancer Center - Indianapolis
- Sidney and Lois Eskenazi Hospital - Indianapolis
- Springmill Medical Center - Indianapolis
Pennsylvania
- Fox Chase Cancer Center - East Norriton Hospital Outpatient Center - East Norriton
- University of Pennsylvania/Abramson Cancer Center - Philadelphia
- Fox Chase Cancer Center - Philadelphia
New York
- Mount Sinai Hospital - New York
- Memorial Sloan Kettering Cancer Center - New York
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2016-05-04 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What the registry record for NCT02398773 still lists
NCT02398773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 164-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (40% lower).
The record links to 4 conditions, with HER2/Neu Negative appearing as the primary indexed condition, and to 4 interventions - of which Computed Tomography is the first listed.
NCT02398773 names 20 study sites across 13 states, led by California, Indiana, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02398773 about?
NCT02398773 is a clinical study titled "FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy". This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone ...
What is the current status of trial NCT02398773?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2016-05-04. Estimated completion is 2026-03-31.
What conditions does trial NCT02398773 study?
This clinical trial studies the following conditions: HER2/Neu Negative, Progesterone Receptor Negative, Stage IV Breast Cancer AJCC v6 and v7, Progesterone Receptor Positive.
What interventions are being tested in trial NCT02398773?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Laboratory Biomarker Analysis (OTHER), F-18 16 Alpha-Fluoroestradiol (DRUG).
Who is sponsoring clinical trial NCT02398773?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02398773 being conducted?
This trial has 20 study locations across Alabama, California, Indiana, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02398773's enrollment target sits among peer trials
99 10th of 28 higher than 19 of 28 other HER2/Neu Negative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2/Neu Negative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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