Measuring HER2 levels in metastatic breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of a quantitative HER2 assay in distinguishing between responders and non-responders among patients with HER2-low metastatic breast cancer receiving T-Dxd treatment. It includes patients with confirmed metastatic breast cancer who have a 1+ level of HER2 expression as determined by local laboratories. The study will utilize archival tissue for biomarker assessment and requires measurable disease at the start of treatment. The goal is to improve patient outcomes by identifying those who are likely to benefit from therapy.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of California San Francisco Medical Center
  San Francisco, California, United States Recruiting
• Smilow Cancer Hospital-Derby Care Center
  Derby, Connecticut, United States Recruiting
• Smilow Cancer Hospital Care Center
  Fairfield, Connecticut, United States Recruiting
• Smilow Cancer Hospital at Glastonbury
  Glastonbury, Connecticut, United States Recruiting
• Smilow Cancer Hospital Care Center at Greenwich
  Greenwich, Connecticut, United States Recruiting
• Smilow Cancer Hospital Care Center
  Guilford, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Angela DeMichele, MD — Abramson Cancer Center at Penn Medicine
• Study coordinator: Angela DeMichele, MD
• Email: angela.demichele@pennmedicine.upenn.edu
• Phone: 215-908-2599

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.