Recruiting NCT06551116
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CE-10-IVD.
- Who it may be relevant to
- Registry conditions: HER2-positive Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Diagnostic test CE-10-IVD
Leftover tumor tissue from a routine biopsy will be sent for analysis.
Primary outcome measures
- 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 outcome measures (4)
- 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]
- Real-World Progression Free Survival and Objective Response Rate by estrogen receptor 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]
- Threshold for HER2 QIF and/or mRNA levels [Time frame: 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 [Time frame: from date of first dose of T-DXd to date of last dose of T-DXd for each. Up to 100 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 37 centers
- University of California San Francisco Medical Center — San Francisco
- Smilow Cancer Hospital-Derby Care Center — Derby
- Smilow Cancer Hospital Care Center — Fairfield
- Smilow Cancer Hospital at Glastonbury — Glastonbury
- Smilow Cancer Hospital Care Center at Greenwich — Greenwich
- Smilow Cancer Hospital Care Center — Guilford
- Smilow Cancer Hospital at Saint Francis — Hartford
- Yale-New Haven Hospital North Haven Medical Center — New Haven
- … and 29 more centers
Identifiers
NCT: NCT06551116 · UPCC 09124 · 855924