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NCT04316117 · ClinicalTrials.gov registry record · Phase 2
Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study
A Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT04316117: Active Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04316117 is a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 138 participants, below the 164-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04316117, a Phase 2 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Breast Carcinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.
Primary Outcome
Will evaluate the performance of FDG-PET/CT response criteria (modified PET Response Criteria in Solid Tumors complete, partial and stable metabolic disease versus progressive metabolic disease) as a binary predictor of PFS in patients with bone-dominant (BD) metastatic breast cancer (MBC) treated with systemic therapy.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- OTHER Fludeoxyglucose F-18
Study Locations (20)
Hawaii
- Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
- Queen's Cancer Cenrer - POB I - Honolulu
- Queen's Medical Center - Honolulu
- Straub Clinic and Hospital - Honolulu
- University of Hawaii Cancer Center - Honolulu
- Hawaii Cancer Care Inc-Liliha - Honolulu
- Queen's Cancer Center - Kuakini - Honolulu
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Medical Center-Mission Bay - San Francisco
- Gene Upshaw Memorial Tahoe Forest Cancer Center - Truckee
Georgia
- Grady Health System - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Delaware
- Bayhealth Hospital Kent Campus - Dover
Florida
- GenesisCare USA - Aventura FP - Aventura
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2027-08-31 |
| Phase | Phase 2 |
What the registry record for NCT04316117 still lists
NCT04316117 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 164-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (16% lower).
The record links to 4 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Computed Tomography is the first listed.
NCT04316117 names 20 study sites across 7 states, led by Hawaii, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04316117 about?
NCT04316117 is a clinical study titled "Using FDG-PET/CT to Assess Response of Bone-Dominant Metastatic Breast Cancer, FEATURE Study". This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity ...
What is the current status of trial NCT04316117?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2020-09-15. Estimated completion is 2027-08-31.
What conditions does trial NCT04316117 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8.
What interventions are being tested in trial NCT04316117?
The interventions under investigation include: Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Fludeoxyglucose F-18 (OTHER).
Who is sponsoring clinical trial NCT04316117?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04316117 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04316117's enrollment target sits among peer trials
138 10th of 59 higher than 50 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 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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