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

ConditionHER2-positive Metastatic Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patients with HER2 IHC1+ metastatic breast cancer, histologically confirmed

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CE-10-IVD

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: HER2 Assay1 intervention

Trial outcomes

Primary outcomes

1

Real-World Objective Response Rate

Association between quantitative HER2 expression (as a continuous variable) and 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

Secondary outcomes

1

Real-World Progression Free Survival

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

Time frame
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

Time frame
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."

Time frame
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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abramson Cancer Center at Penn Medicine

Lead sponsor

Translational Breast Cancer Research Consortium

Collaborator

Danaher Inc.

Collaborator

Source ClinicalTrials.gov
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