Analysis of Circulating Tumor DNA (ctDNA) in HER2-low Advanced/Metastatic Breast Cancer

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a specific type of breast cancer known as HER2-low advanced or metastatic breast cancer. In this study, researchers are analyzing a substance called circulating tumor DNA (ctDNA), which is found in the blood and can provide important information about the cancer. The goal is to understand more about this type of cancer and how ctDNA can help in managing it.

To be eligible for the trial, a woman must have been diagnosed with HER2-low breast cancer, which means she has a certain score (1+ or 2+) on a test and does not have amplified HER2 levels confirmed by another test. Participants should be at a stage where the cancer has spread (advanced or metastatic) and must agree to participate by signing consent forms. Throughout the study, participants can expect to undergo blood tests to check their ctDNA levels and will need to be available for follow-up appointments. This trial is currently recruiting participants, so if you meet the criteria, it could be a valuable opportunity to contribute to important research in breast cancer treatment.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • Participants diagnosed with HER2-low breast cancer, defined as IHC score 1+ or 2+ and not amplified at in situ hybridization (ISH) test as confirmed by local laboratory testing.
• • Participants should be at advanced or metastatic setting prior to treatment.
• • Written informed consent (Accordo di Partecipazione alla Ricerca Scientifica) and specific informed consent to the study must be signed and dated by the patient and the doctor prior to inclusion.
• • Patients must be accessible for follow-up.