QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor: Abramson Cancer Center at Penn Medicine
Study ID: NCT06551116
Status: Recruiting

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Conditions

HER2-positive Metastatic Breast Cancer

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

CE-10-IVD — DIAGNOSTIC_TEST
Leftover tumor tissue from a routine biopsy will be sent for analysis.

Study Details

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.

Key Dates

Start date: Oct 10, 2024
Status verified: May 2025
Primary completion: Sep 1, 2029
Completion: Sep 1, 2029

Study Design

Enrollment: 200 participants (estimated)

Arms

Arm: HER2 Assay
Analysis of HER2 expression via QIF and mRNA assays

Primary Outcome Measure

Real-World Objective Response Rate [ Time Frame: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months ]

Central Contacts

Angela DeMichele, MD
215-908-2599
[email protected]

Locations (37)

Facility	City	State	ZIP	Site coordinators
University of California San Francisco Medical Center	San Francisco	California	94143	Emma Brophy [email protected]
Smilow Cancer Hospital-Derby Care Center	Derby	Connecticut	06418	Carl Brown [email protected]
Smilow Cancer Hospital Care Center	Fairfield	Connecticut	06824	Carl Brown [email protected]
Smilow Cancer Hospital at Glastonbury	Glastonbury	Connecticut	06033	Carl Brown [email protected]
Smilow Cancer Hospital Care Center at Greenwich	Greenwich	Connecticut	06830	Carl Brown [email protected]
Smilow Cancer Hospital Care Center	Guilford	Connecticut	06437	Carl Brown [email protected]
Smilow Cancer Hospital at Saint Francis	Hartford	Connecticut	06105	Carl Brown [email protected]
Yale Cancer Center	New Haven	Connecticut	06511	Carl Brown, MHS [email protected] Adriana Kahn, MD (PRINCIPAL_INVESTIGATOR)
Yale-New Haven Hospital North Haven Medical Center	New Haven	Connecticut	06473	Carl Brown [email protected]
Smilow Cancer Hospital Care Center at Long Ridge	Stamford	Connecticut	06901	Carl Brown [email protected]
Smilow Cancer Hospital-Torrington Care Center	Torrington	Connecticut	06790	Carl Brown [email protected]
Smilow Cancer Hospital Care Center	Trumbull	Connecticut	06611	Carl Brown [email protected]
Smilow Cancer Hospital-Waterbury Care Center	Waterbury	Connecticut	06708	Carl Brown [email protected]
Smilow Cancer Hospital Care Center - Waterford	Waterford	Connecticut	06385	Carl Brown [email protected]
Georgetown University - Lombardi CCC	Washington D.C.	District of Columbia	20007	Antonella Novielli [email protected]
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	20010	Antonella Novielli [email protected]
Sibley Memorial Hospital	Washington D.C.	District of Columbia	20016	Stephanie Grunwald [email protected]
University of Chicago Medical Center	Chicago	Illinois	60637	Vhenyse Encarnacion [email protected]
University of Chicago Comprehensive Cancer Center at Silver Cross	New Lenox	Illinois	60451	Vhenyse Encarnacion [email protected]
University of Chicago Medicine-Orland Park	Orland Park	Illinois	60462	Vhenyse Encarnacion [email protected]
University of Chicago Medicine Northwest Indiana	Crown Point	Indiana	46307	Vhenyse Encarnacion [email protected]
John's Hopkins Hospital	Baltimore	Maryland	21287	Jessica Jelinek [email protected]
Penn Medicine Princeton Medical Center	Plainsboro	New Jersey	08536	Mommen Ali [email protected]
Montefiore Einstein Medical Center	The Bronx	New York	10467	Alisia Laird [email protected]
UNC Chapel Hill	Chapel Hill	North Carolina	27599	Mireille Leone [email protected]
Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Angela DeMichele, MD [email protected] 855-216-0098 Angela DeMichele, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	15213	AJ Jackson [email protected]
UPMC Hillman CC	Pittsburgh	Pennsylvania	15232	AJ Jackson [email protected]
Smilow Cancer Hospital Care Center	Westerly	Rhode Island	02891	Carl Brown [email protected]
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center	Houston	Texas	77054	Emily Mowatt [email protected]
Ben Taub General Hospital	Houston	Texas	77030	Emily Mowatt [email protected]
MD Anderson Cancer center	Houston	Texas	77030	Cynthia Tamez [email protected]
MD Anderson Cancer Center	Houston	Texas	77079	Cynthia Tamez [email protected]
MD Anderson Cancer center	League City	Texas	77573	Cynthia Tamez [email protected]
MD Anderson Cancer Center	Sugar Land	Texas	77478	Cynthia Tamez [email protected]
MD Anderson Cancer center	Woodland	Texas	77384	Cynthia Tamez [email protected]
University of Washington - Fred Hutchinson Cancer Center	Seattle	Washington	98109	Emma Jackson [email protected]

Find similar trials in San Francisco, CA

By research site

University of California San Francisco Medical Center· San Francisco, CA Smilow Cancer Hospital-Derby Care Center· Derby, CT Smilow Cancer Hospital Care Center· Fairfield, CT Smilow Cancer Hospital at Glastonbury· Glastonbury, CT Smilow Cancer Hospital Care Center at Greenwich· Greenwich, CT Smilow Cancer Hospital Care Center· Guilford, CT

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