Clinical trial NCT06551116: QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Official title: QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HER2-positive Metastatic Breast Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: Translational Breast Cancer Research Consortium
name: Danaher Inc.
First posted: 2024-08-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with HER2 IHC1+ metastatic breast cancer, histologically confirmed

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Real-World Objective Response Rate
timeFrame: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
Secondary outcomes:
measure: Real-World Progression Free Survival
timeFrame: from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months
measure: Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression
timeFrame: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
measure: Threshold for HER2 QIF and/or mRNA levels
timeFrame: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
measure: Association between combined mRNA + QIF and real-world Objective Response Rate
timeFrame: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months
Other outcomes:
Locations:
city: Derby
country: United States
facility: Smilow Cancer Hospital-Derby Care Center
state: Connecticut
city: Fairfield
country: United States
facility: Smilow Cancer Hospital Care Center
state: Connecticut
city: Glastonbury
country: United States
facility: Smilow Cancer Hospital at Glastonbury
state: Connecticut
city: Greenwich
country: United States
facility: Smilow Cancer Hospital Care Center at Greenwich
state: Connecticut
city: Guilford
country: United States
facility: Smilow Cancer Hospital Care Center
state: Connecticut
city: Hartford
country: United States
facility: Smilow Cancer Hospital at Saint Francis
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital North Haven Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Stamford
country: United States
facility: Smilow Cancer Hospital Care Center at Long Ridge
state: Connecticut
city: Torrington
country: United States
facility: Smilow Cancer Hospital-Torrington Care Center
state: Connecticut
city: Trumbull
country: United States
facility: Smilow Cancer Hospital Care Center
state: Connecticut
city: Waterbury
country: United States
facility: Smilow Cancer Hospital-Waterbury Care Center
state: Connecticut
city: Waterford
country: United States
facility: Smilow Cancer Hospital Care Center - Waterford
state: Connecticut
city: Washington
country: United States
facility: Georgetown University - Lombardi CCC
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: New Lenox
country: United States
facility: University of Chicago Comprehensive Cancer Center at Silver Cross
state: Illinois
city: Orland Park
country: United States
facility: University of Chicago Medicine-Orland Park
state: Illinois
city: Crown Point
country: United States
facility: University of Chicago Medicine Northwest Indiana
state: Indiana
city: Baltimore
country: United States
facility: John's Hopkins Hospital
state: Maryland
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Westerly
country: United States
facility: Smilow Cancer Hospital Care Center
state: Rhode Island
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: League City
country: United States
facility: MD Anderson Cancer center
state: Texas
city: Sugar Land
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Woodland
country: United States
facility: MD Anderson Cancer center
state: Texas
city: Seattle
country: United States
facility: University of Washington - Fred Hutchinson Cancer Center
state: Washington
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Angela DeMichele, MD
role: PRINCIPAL_INVESTIGATOR
References: