Recruiting

HER2 Low

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06551116

Conditions

HER2-positive Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CE-10-IVD

Study Details

Brief 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.

Conditions

HER2-positive Metastatic Breast Cancer

Study ID

NCT06551116

Start date

Oct 10, 2024

Status verified date

Jul, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women and men age > 18 years
  • Metastatic breast cancer, histologically- confirmed. Any estrogen receptor (ER) status is allowed. ER status will be determined by local laboratory assessment utilizing ASCO/CAP guidelines.
  • Primary and/or metastatic tumor with 1+ level of expression of HER2 by immunohistochemistry as determined by local laboratory assessment utilizing ASCO/CAP guidelines.
  • Measurable disease by cross-sectional imaging at the start of treatment. Patients with measurable bone-only disease or active brain metastases are eligible.
  • Archival tissue available for biomarker assessment. One specimen should be the most recent metastatic biopsy. If HER2 1+ status was determined on a different specimen (either primary or metastatic tissue), that specimen is also required. Samples obtained from bone metastases that were processed via decalcification methods are not eligible.
  • Intention to initiate therapy with T-DXd (Enhertu) at FDA-approved dose and schedule as next line of therapy. If T-DXd was already initiated, patients must be registered within 30 days of initiation.
  • Ability to provide informed consent

Exclusion Criteria:

  • Concurrent Her2-overexpressing metastatic breast cancer (as confirmed by a metastatic biopsy with IHC 3+ or IHC 2+ with FISH amplified as per standard ASCO/CAP guidelines)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

HER2 Assay

Analysis of HER2 expression via QIF and mRNA assays

Interventions

CE-10-IVD

Leftover tumor tissue from a routine biopsy will be sent for analysis.

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 and Locations

Central contacts

Angela DeMichele, MD

215-908-2599angela.demichele@pennmedicine.upenn.edu

Locations

University of California San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94143

Contacts

Emma Brophy

Emma.Brophy@ucsf.edu

Smilow Cancer Hospital-Derby Care Center

Recruiting

Derby, Connecticut, United States, 06418

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital Care Center

Recruiting

Fairfield, Connecticut, United States, 06824

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital at Glastonbury

Recruiting

Glastonbury, Connecticut, United States, 06033

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital Care Center at Greenwich

Recruiting

Greenwich, Connecticut, United States, 06830

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital Care Center

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital at Saint Francis

Recruiting

Hartford, Connecticut, United States, 06105

Contacts

Carl Brown

carl.brown@yale.edu

Yale-New Haven Hospital North Haven Medical Center

Recruiting

New Haven, Connecticut, United States, 06473

Contacts

Carl Brown

carl.brown@yale.edu

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Carl Brown, MHS

carl.brown@yale.edu

Principal Investigator:

Adriana Kahn, MD

Smilow Cancer Hospital Care Center at Long Ridge

Recruiting

Stamford, Connecticut, United States, 06901

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital-Torrington Care Center

Recruiting

Torrington, Connecticut, United States, 06790

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital Care Center

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital-Waterbury Care Center

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Carl Brown

carl.brown@yale.edu

Smilow Cancer Hospital Care Center - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Carl Brown

carl.brown@yale.edu

Georgetown University - Lombardi CCC

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Antonella Novielli

noviella@georgetown.edu

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Antonella Novielli

noviella@georgetown.edu

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Stephanie Grunwald

sgrunwa1@jh.edu

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Vhenyse Encarnacion

vhenyse.encarnacion@bsd.uchicago.edu

University of Chicago Comprehensive Cancer Center at Silver Cross

Recruiting

New Lenox, Illinois, United States, 60451

Contacts

Vhenyse Encarnacion

vhenyse.encarnacion@bsd.uchicago.edu

University of Chicago Medicine-Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Vhenyse Encarnacion

vhenyse.encarnacion@bsd.uchicago.edu

University of Chicago Medicine Northwest Indiana

Recruiting

Crown Point, Indiana, United States, 46307

Contacts

Vhenyse Encarnacion

vhenyse.encarnacion@bsd.uchicago.edu

John's Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Jessica Jelinek

jnovotn3@jhmi.edu

Penn Medicine Princeton Medical Center

Recruiting

Plainsboro, New Jersey, United States, 08536

Contacts

Mommen Ali

Syed.Ali@PennMedicine.upenn.edu

Montefiore Einstein Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Alisia Laird

allaird@montefiore.org

UNC Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Mireille Leone

mireille_leone@med.unc.edu

Abramson Cancer Center of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Angela DeMichele, MD

855-216-0098BreastCancerClinicalTrials@pennmedicine.upenn.edu

Principal Investigator:

Angela DeMichele, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

AJ Jackson

jacksonac@upmc.edu

UPMC Hillman CC

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

AJ Jackson

jacksonac@upmc.edu

Smilow Cancer Hospital Care Center

Recruiting

Westerly, Rhode Island, United States, 02891

Contacts

Carl Brown

carl.brown@yale.edu

Ben Taub General Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Emily Mowatt

Emily.Mowatt@bcm.edu

MD Anderson Cancer center

Recruiting

Houston, Texas, United States, 77030

Contacts

Cynthia Tamez

CTamez@mdanderson.org

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77054

Contacts

Emily Mowatt

Emily.Mowatt@bcm.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77079

Contacts

Cynthia Tamez

CTamez@mdanderson.org

MD Anderson Cancer center

Recruiting

League City, Texas, United States, 77573

Contacts

Cynthia Tamez

CTamez@mdanderson.org

MD Anderson Cancer Center

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Cynthia Tamez

CTamez@mdanderson.org

MD Anderson Cancer center

Recruiting

Woodland, Texas, United States, 77384

Contacts

Cynthia Tamez

CTamez@mdanderson.org

University of Washington - Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Emma Jackson

ejackso2@fredhutch.org

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-07-08.