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

Recruiting now

Conditions studied: HER2-negative Breast Cancer, Hormone-receptor-positive Breast Cancer, Metastatic Breast Cancer, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, HER2 Negative Breast Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Breast Carcinoma

In brief

This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.

Key facts

Study ID

NCT06388122

Run by

Mayo Clinic

People needed

100

Starts

2024-04-30

Expected to finish

2031-06-15

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Group 5: scheduled to initiate or are currently receiving 1st line therapy of an FDA-approved CDK4/6 inhibitor (ribociclib or abemaciclib) with an FDA approved endocrine therapy for stage 2 or stage 3 adjuvant HR+ BC
• 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.

You may not qualify if…

• 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 it is running

• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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