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

NCT06551116 | Recruiting

• 2 other identifiers: UPCC 09124855924
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 36

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

Outcome Measures

Primary Outcomes (1)

• Real-World Objective Response Rate

  Association between quantitative HER2 expression (as a continuous variable) and real-world objective response rate

  from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months

Secondary Outcomes (4)

• Real-World Progression Free Survival

  from date of first dose of T-DXd to date of last dose of T-DXd for each.Up to 100 months

• Real-World Progression Free Survival and Objective Response Rate by estrogen receptor expression

  from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months

• Threshold for HER2 QIF and/or mRNA levels

  from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months

• Association between combined mRNA + QIF and real-world Objective Response Rate

  from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months

Study Arms (1)

HER2 Assay

Analysis of HER2 expression via QIF and mRNA assays

Diagnostic Test: CE-10-IVD

Interventions

CE-10-IVD DIAGNOSTIC_TEST

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

HER2 Assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HER2 IHC1+ metastatic breast cancer, histologically confirmed

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Translational Breast Cancer Research Consortium: collaborator
• Danaher Inc.: collaborator

Study Sites (36)

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

RECRUITING

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, 06418, United States

RECRUITING

Smilow Cancer Hospital Care Center

Fairfield, Connecticut, 06824, United States

RECRUITING

Smilow Cancer Hospital at Glastonbury

Glastonbury, Connecticut, 06033, United States

RECRUITING

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

RECRUITING

Smilow Cancer Hospital Care Center

Guilford, Connecticut, 06437, United States

RECRUITING

Smilow Cancer Hospital at Saint Francis

Hartford, Connecticut, 06105, United States

RECRUITING

Yale-New Haven Hospital North Haven Medical Center

New Haven, Connecticut, 06473, United States

RECRUITING

Yale Cancer Center

New Haven, Connecticut, 06511, United States

RECRUITING

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06901, United States

RECRUITING

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

RECRUITING

Smilow Cancer Hospital Care Center

Trumbull, Connecticut, 06611, United States

RECRUITING

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

RECRUITING

Georgetown University - Lombardi CCC

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

RECRUITING

MedStar Washington Hospital Center

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

RECRUITING

Sibley Memorial Hospital

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

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of Chicago Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States

RECRUITING

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States

RECRUITING

University of Chicago Medicine Northwest Indiana

Crown Point, Indiana, 46307, United States

RECRUITING

John's Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Montefiore Einstein Medical Center

The Bronx, New York, 10467, United States

RECRUITING

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

UPMC Hillman CC

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Smilow Cancer Hospital Care Center

Westerly, Rhode Island, 02891, United States

RECRUITING

Ben Taub General Hospital

Houston, Texas, 77030, United States

RECRUITING

MD Anderson Cancer center

Houston, Texas, 77030, United States

RECRUITING

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77054, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77079, United States

RECRUITING

MD Anderson Cancer center

League City, Texas, 77573, United States

RECRUITING

MD Anderson Cancer Center

Sugar Land, Texas, 77478, United States

RECRUITING

MD Anderson Cancer center

Woodland, Texas, 77384, United States

RECRUITING

University of Washington - Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patients can consent to having the study team retain and utilize biospecimens for future research.

Study Officials

• Angela DeMichele, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela DeMichele, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 13, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 5, 2025

Record last verified: 2025-05

Locations

US (36)