DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients

Launched by MAYO CLINIC · Apr 26, 2024

Keywords

ClinConnect Summary

This clinical trial, called DiviTum®TKa, is studying a special test that measures a substance in the blood called thymidine kinase activity (TKa). The goal is to see how useful this test can be for women with hormone-receptor-positive (HR+) metastatic breast cancer, which means their cancer has spread and responds to hormone treatments. The trial will focus on women who are starting or continuing treatment with approved hormone therapies and certain medications known as CDK4/6 inhibitors.

To participate, women must be pre- or post-menopausal and have HR+ metastatic breast cancer. They can be starting their first treatment or be on their second or later line of therapy. It's important to note that this trial is open only to women, and those currently receiving treatment for another type of cancer or those with early-stage breast cancer cannot participate. If you qualify, you will have regular check-ups during the trial, and your healthcare team will closely monitor your health and treatment response. This study aims to help doctors understand better how to treat breast cancer patients effectively.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• * Pre- or post-menopausal HR+ metastatic breast cancer patients who are:
• • Group 1: scheduled to initiate 1st line combination therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ metastatic breast cancer (mBC).
• • Group 2: scheduled to initiate second or later lines of therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) with or without an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
• • Group 3: currently receiving 1st line therapy with an FDA-approved CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) and an FDA-approved endocrine therapy for pre- or post-menopausal HR+ mBC.
• • Group 4: scheduled to initiate, or are currently receiving, 1st or 2nd line therapy of an FDA approved endocrine therapy (single agent) for pre- or post-menopausal HR+ mBC.
• • NOTE: Patients that meet eligibility criteria for any of the above groups that are already enrolled in an ongoing clinical trial are eligible for co-enrollment to this observational study.
• Exclusion Criteria:
• • Treatment including investigational agent or therapies
• • Early breast cancer diagnosis
• • Male breast cancer
• • Currently receiving treatment for other active malignancy at time of registration
• • EXCEPTIONS: Nonmelanoma skin cancer or carcinoma-in-situ (e.g. of cervix, prostate)
• • Inability to give written informed consent