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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
HER2 Assay Analysis of HER2 expression via QIF and mRNA assays
  • Diagnostic Test: CE-10-IVD
    Leftover tumor tissue from a routine biopsy will be sent for analysis.

Recruiting Locations

University of California San Francisco Medical Center
San Francisco, California 94143
Contact:
Emma Brophy
Emma.Brophy@ucsf.edu

Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital Care Center
Fairfield, Connecticut 06824
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital at Glastonbury
Glastonbury, Connecticut 06033
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital Care Center
Guilford, Connecticut 06437
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital at Saint Francis
Hartford, Connecticut 06105
Contact:
Carl Brown
carl.brown@yale.edu

Yale-New Haven Hospital North Haven Medical Center
New Haven, Connecticut 06473
Contact:
Carl Brown
carl.brown@yale.edu

Yale Cancer Center
New Haven, Connecticut 06511
Contact:
Carl Brown, MHS
carl.brown@yale.edu

Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06901
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut 06790
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital Care Center
Trumbull, Connecticut 06611
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
Contact:
Carl Brown
carl.brown@yale.edu

Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
Contact:
Carl Brown
carl.brown@yale.edu

Georgetown University - Lombardi CCC
Washington D.C., District of Columbia 20007
Contact:
Antonella Novielli
noviella@georgetown.edu

MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010
Contact:
Antonella Novielli
noviella@georgetown.edu

Sibley Memorial Hospital
Washington D.C., District of Columbia 20016
Contact:
Stephanie Grunwald
sgrunwa1@jh.edu

University of Chicago Medical Center
Chicago, Illinois 60637
Contact:
Vhenyse Encarnacion
vhenyse.encarnacion@bsd.uchicago.edu

University of Chicago Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
Contact:
Vhenyse Encarnacion
vhenyse.encarnacion@bsd.uchicago.edu

University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
Contact:
Vhenyse Encarnacion
vhenyse.encarnacion@bsd.uchicago.edu

University of Chicago Medicine Northwest Indiana
Crown Point, Indiana 46307
Contact:
Vhenyse Encarnacion
vhenyse.encarnacion@bsd.uchicago.edu

John's Hopkins Hospital
Baltimore, Maryland 21287
Contact:
Jessica Jelinek
jnovotn3@jhmi.edu

Penn Medicine Princeton Medical Center
Plainsboro, New Jersey 08536
Contact:
Mommen Ali
Syed.Ali@PennMedicine.upenn.edu

Montefiore Einstein Medical Center
The Bronx, New York 10467
Contact:
Alisia Laird
allaird@montefiore.org

UNC Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Mireille Leone
mireille_leone@med.unc.edu

Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Angela DeMichele, MD
855-216-0098
BreastCancerClinicalTrials@pennmedicine.upenn.edu

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
AJ Jackson
jacksonac@upmc.edu

UPMC Hillman CC
Pittsburgh, Pennsylvania 15232
Contact:
AJ Jackson
jacksonac@upmc.edu

Smilow Cancer Hospital Care Center
Westerly, Rhode Island 02891
Contact:
Carl Brown
carl.brown@yale.edu

Ben Taub General Hospital
Houston, Texas 77030
Contact:
Emily Mowatt
Emily.Mowatt@bcm.edu

MD Anderson Cancer center
Houston, Texas 77030
Contact:
Cynthia Tamez
CTamez@mdanderson.org

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77054
Contact:
Emily Mowatt
Emily.Mowatt@bcm.edu

MD Anderson Cancer Center
Houston, Texas 77079
Contact:
Cynthia Tamez
CTamez@mdanderson.org

MD Anderson Cancer center
League City, Texas 77573
Contact:
Cynthia Tamez
CTamez@mdanderson.org

MD Anderson Cancer Center
Sugar Land, Texas 77478
Contact:
Cynthia Tamez
CTamez@mdanderson.org

MD Anderson Cancer center
Woodland, Texas 77384
Contact:
Cynthia Tamez
CTamez@mdanderson.org

University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington 98109
Contact:
Emma Jackson
ejackso2@fredhutch.org

More Details

Status
Recruiting
Sponsor
Abramson Cancer Center at Penn Medicine

Study Contact

Angela DeMichele, MD
215-908-2599
angela.demichele@pennmedicine.upenn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.