Measuring a biomarker for breast cancer treatment effectiveness
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
This study is testing if measuring a specific biomarker can help doctors understand how well hormone treatments are working for people with advanced breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06388122 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical utility of measuring thymidine kinase activity (TKa) in patients with hormone-receptor-positive metastatic breast cancer who are undergoing treatment with approved endocrine therapies, either alone or in combination with CDK4/6 inhibitors. The study will involve collecting biospecimens from participants to assess the relationship between TKa levels and treatment efficacy. Eligible patients include those starting or currently receiving specific lines of therapy for their condition. The findings could provide insights into optimizing treatment strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are pre- or post-menopausal women with hormone-receptor-positive metastatic breast cancer receiving or scheduled to receive specific therapies.
Not a fit: Patients with HER2-positive breast cancer or those not receiving the specified therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor breast cancer treatments based on biomarker levels, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored biomarker assessments in breast cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Pooja Advani, MBBS, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.