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

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

  • HER2-positive Metastatic Breast Cancer

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

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

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

More Details

Status
Recruiting
Sponsor
Abramson Cancer Center at Penn Medicine

Study Contact

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