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NCT06551116 · ClinicalTrials.gov registry record
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
A clinical trial of HER2-positive Metastatic Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
- Recruiting
- Registry status
- 200
- Enrollment target
- 20
- Study locations
NCT06551116: Recruiting study of HER2-positive Metastatic Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
NCT06551116 is a study of HER2-positive Metastatic Breast Cancer that is actively recruiting participants, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 200 participants, above the 106-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06551116, a study of HER2-positive Metastatic Breast Cancer, is actively recruiting participants, sponsored by Abramson Cancer Center at Penn Medicine.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
Primary Outcome
Association between quantitative HER2 expression (as a continuous variable) and real-world objective response rate
Conditions Studied
Interventions
- DIAGNOSTIC_TEST CE-10-IVD
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center - Fairfield
- Smilow Cancer Hospital at Glastonbury - Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich
- Smilow Cancer Hospital Care Center - Guilford
- Smilow Cancer Hospital at Saint Francis - Hartford
- Yale-New Haven Hospital North Haven Medical Center - New Haven
- Yale Cancer Center - New Haven
- Smilow Cancer Hospital Care Center at Long Ridge - Stamford
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
District of Columbia
- Georgetown University - Lombardi CCC - Washington D.C.
- MedStar Washington Hospital Center - Washington D.C.
- Sibley Memorial Hospital - Washington D.C.
Illinois
- University of Chicago Medical Center - Chicago
- University of Chicago Comprehensive Cancer Center at Silver Cross - New Lenox
- University of Chicago Medicine-Orland Park - Orland Park
California
- University of California San Francisco Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-10-10 |
| Est. Completion | 2029-09-01 |
What NCT06551116 shows while recruiting
NCT06551116 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 106-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (89% higher).
The record links to 1 condition, with HER2-positive Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which CE-10-IVD is the first listed.
NCT06551116 names 20 study sites across 4 states, led by Connecticut, District of Columbia, Illinois.
Frequently Asked Questions
What is clinical trial NCT06551116 about?
NCT06551116 is a clinical study titled "QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer". This study will assess whether a quantitative, HER2 assay can accurately and reliably discriminate between responders and non-responders among patients with HER2 IHCI+ metastatic breast cancer who are receiving T-Dxd.
What is the current status of trial NCT06551116?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2024-10-10. Estimated completion is 2029-09-01.
What conditions does trial NCT06551116 study?
This clinical trial studies the following conditions: HER2-positive Metastatic Breast Cancer.
What interventions are being tested in trial NCT06551116?
The interventions under investigation include: CE-10-IVD (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06551116?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06551116 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06551116's enrollment target sits among peer trials
200 2nd of 11 the highest of 11 other HER2-positive Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Metastatic Breast Cancer 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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