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HER2-positive Metastatic Breast CancerNCT06551116

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

An observational study of HER2-positive Metastatic Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 37 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Metastatic Breast Cancer
What is being tested?
CE-10-IVD
How many people
200 participants
Where
37 sitesUnited States
Study dates
10 Oct 2024to 1 Sep 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with HER2 IHC1+ metastatic breast cancer, histologically confirmed

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

37 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Angela DeMichele, MD contact

215-908-2599

angela.demichele@pennmedicine.upenn.edu

37 sites in 1 country

United States37 sites, 37 recruiting

  • John's Hopkins Hospital

    Baltimore, Maryland, 21287

    Jessica Jelinek, jnovotn3@jhmi.edu

    Recruiting

  • UNC Chapel Hill

    Chapel Hill, North Carolina, 27599

    Mireille Leone, mireille_leone@med.unc.edu

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Vhenyse Encarnacion, vhenyse.encarnacion@bsd.uchicago.edu

    Recruiting

  • University of Chicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

    Vhenyse Encarnacion, vhenyse.encarnacion@bsd.uchicago.edu

    Recruiting

  • Smilow Cancer Hospital-Derby Care Center

    Derby, Connecticut, 06418

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital Care Center

    Fairfield, Connecticut, 06824

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital at Glastonbury

    Glastonbury, Connecticut, 06033

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital Care Center

    Guilford, Connecticut, 06437

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital at Saint Francis

    Hartford, Connecticut, 06105

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Ben Taub General Hospital

    Houston, Texas, 77030

    Emily Mowatt, Emily.Mowatt@bcm.edu

    Recruiting

  • MD Anderson Cancer center

    Houston, Texas, 77030

    Cynthia Tamez, CTamez@mdanderson.org

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77054

    Emily Mowatt, Emily.Mowatt@bcm.edu

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77079

    Cynthia Tamez, CTamez@mdanderson.org

    Recruiting

  • MD Anderson Cancer center

    League City, Texas, 77573

    Cynthia Tamez, CTamez@mdanderson.org

    Recruiting

  • Yale-New Haven Hospital North Haven Medical Center

    New Haven, Connecticut, 06473

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06511

    Carl Brown, MHS, carl.brown@yale.edu

    Adriana Kahn, MD

    Recruiting

  • University of Chicago Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

    Vhenyse Encarnacion, vhenyse.encarnacion@bsd.uchicago.edu

    Recruiting

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

    Vhenyse Encarnacion, vhenyse.encarnacion@bsd.uchicago.edu

    Recruiting

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Angela DeMichele, MD, 855-216-0098, BreastCancerClinicalTrials@pennmedicine.upenn.edu

    Angela DeMichele, MD

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    AJ Jackson, jacksonac@upmc.edu

    Recruiting

  • UPMC Hillman CC

    Pittsburgh, Pennsylvania, 15232

    AJ Jackson, jacksonac@upmc.edu

    Recruiting

  • Penn Medicine Princeton Medical Center

    Plainsboro, New Jersey, 08536

    Mommen Ali, Syed.Ali@PennMedicine.upenn.edu

    Recruiting

  • University of California San Francisco Medical Center

    San Francisco, California, 94143

    Emma Brophy, Emma.Brophy@ucsf.edu

    Recruiting

  • University of Washington - Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Emma Jackson, ejackso2@fredhutch.org

    Recruiting

  • Smilow Cancer Hospital Care Center at Long Ridge

    Stamford, Connecticut, 06901

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • MD Anderson Cancer Center

    Sugar Land, Texas, 77478

    Cynthia Tamez, CTamez@mdanderson.org

    Recruiting

  • Montefiore Einstein Medical Center

    The Bronx, New York, 10467

    Alisia Laird, allaird@montefiore.org

    Recruiting

  • Smilow Cancer Hospital-Torrington Care Center

    Torrington, Connecticut, 06790

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital Care Center

    Trumbull, Connecticut, 06611

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Georgetown University - Lombardi CCC

    Washington D.C., District of Columbia, 20007

    Antonella Novielli, noviella@georgetown.edu

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Antonella Novielli, noviella@georgetown.edu

    Recruiting

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Stephanie Grunwald, sgrunwa1@jh.edu

    Recruiting

  • Smilow Cancer Hospital-Waterbury Care Center

    Waterbury, Connecticut, 06708

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital Care Center - Waterford

    Waterford, Connecticut, 06385

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • Smilow Cancer Hospital Care Center

    Westerly, Rhode Island, 02891

    Carl Brown, carl.brown@yale.edu

    Recruiting

  • MD Anderson Cancer center

    Woodland, Texas, 77384

    Cynthia Tamez, CTamez@mdanderson.org

    Recruiting

Other trials in United States

About this study

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.

Being tested
CE-10-IVD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CE-10-IVDDiagnostic test

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

Study groups in NCT06551116
Study groupRoleWhat they receive
HER2 AssayAnalysis of HER2 expression via QIF and mRNA assays
Receives: Diagnostic Test: CE-10-IVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Real-World Objective Response Rate

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

    Measured: 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)

  1. Real-World Progression Free Survival

    Association between quantitative HER2 expression (as a continuous variable) and real world Progression Free Survival

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

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

    Association between HER2 expression by quantitative immunofluorescence and mRNA in HER2 IHC 1+ tumors and both rwORR and rwPFS, stratified by mRNA ER expression

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

  3. Threshold for HER2 QIF and/or mRNA levels

    cut-off value for HER2 QIF, mRNA and the combination below which patients will not respond to T-DXd."

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

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

    Comparison, based on rwORR, of a linear combination of HER2 QIF and mRNA, versus either alone in ability to discriminate T-DXd responders from non- responders

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start10 Oct 2024
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551116
Sponsor's protocol ID
UPCC 09124
Other IDs
855924
Status last verified
Jul 2026
First submitted
29 Jul 2024
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of HER2-positive Metastatic Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Angela DeMichele, MD (215-908-2599, angela.demichele@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06551116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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