A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients

Launched by MENARINI SILICON BIOSYSTEMS, INC · Feb 13, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how a special test called the CellSearch Circulating Tumor Cells (CTC) test can help doctors make better decisions about treating patients with metastatic breast cancer (MBC). The CTC test looks for cancer cells in the blood and can provide important information about specific markers related to the cancer, which may help guide treatment choices. The study will involve patients who have invasive breast cancer that has spread and who may be starting a new line of therapy.

To participate in this trial, patients must be at least 18 years old and meet certain criteria, such as having specific types of metastatic breast cancer. For example, they might be those with hormone receptor-positive, HER2-negative breast cancer or those with HER2-positive cancer who are beginning a second-line treatment. Participants will have blood samples taken as part of their routine care, and this trial aims to see how the test results can help in monitoring their cancer and adjusting treatment as needed. It’s important to note that the trial is not currently enrolling participants, and pregnant individuals are not eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease.
• • HR+/HER2 negative or triple negative (TN) subjects prior to starting first line therapy or beyond in the metastatic setting.
• • OR HER2+ subjects prior to starting second line therapy or beyond in the metastatic setting.
• • Subject must have the CTC HER2, ER, PD-L1, and cfDNA/RNA tests ordered during routine patient care.
• • Age \> 18 years.
• Exclusion Criteria:
• • Participant is pregnant.
• • Inability to provide blood samples based on the judgment of the treating physician.