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

ConditionsHER2-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

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Treatment including investigational agent or therapies

Early breast cancer diagnosis

Male breast cancer

Currently receiving treatment for other active malignancy at time of registration

Trial population

Adult Patients \>= 18 years old with diagnosis of metastatic HR positive HER2 negative breast cancer or early breast cancer HR positive HER2 negative that will be or are currently being treated with standard of care endocrine therapy +/- CDK 4/6 inhibitors.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Biospecimen Collection
Procedure/Surgery
Undergo blood sample collection

Treatment groups

100 Participants

are divided into 5 treatment groups

Group A: Group 1 (initiating 1st line CDK4/6 & endocrine therapy)1 intervention

Group B: Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy)1 intervention

Group C: Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy)1 intervention

Group D: Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)1 intervention

Group E: Group 51 intervention

Trial outcomes

Primary outcomes

DiviTum®TKa assay as an early predictor of primary treatment resistance

Blood samples collected from participants will be assessed using DiviTum®TKa assay for thymidine kinase activity (TKa) levels above Limit of Detection (LOD) as a predictor of primary treatment resistance. Primary treatment resistance will be defined as disease progression in less than 6 months.

Time frame

Every cycle (approximately 28 days) until disease progression up to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

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