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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a test that measures HER2 can tell who will respond to T-DXd (Enhertu). It is for adults with breast cancer that has spread, has a low HER2 level called 1+, and will be treated with T-DXd.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women and men older than 18.
  • Breast cancer that has spread to other parts of the body, confirmed by a tissue sample. Any estrogen receptor (ER) test result is allowed.
  • An original breast tumor or a tumor that has spread must have a HER2 level of 1+ on a lab test called IHC.
  • Cancer must be measurable on scans when treatment starts. Cancer only in the bones or active cancer spread to the brain is allowed if it can be measured.
  • Stored tumor tissue must be available, including the most recent sample from cancer that has spread. If a different sample showed HER2 1+, that sample is also needed. Bone samples treated to remove calcium cannot be used.
  • Plan to start T-DXd (Enhertu) as the next treatment, using the FDA-approved dose and schedule. If treatment has already started, you must join within 30 days of starting.
  • Able to give informed consent, meaning you understand the study and agree to join.

Who can't join

  • Also have breast cancer that has spread and has high HER2 levels. This must be confirmed in a tissue sample by an IHC result of 3+, or an IHC result of 2+ with a FISH test showing extra copies of the HER2 gene.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (37)

CA

CT

DC

IL

IN

MD

NC

NJ

NY

PA

RI

TX

WA