Health Trials

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

ConditionsHER2-negative Breast CancerHormone-receptor-positive Breast CancerMetastatic Breast CancerAnatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8HER2 Negative Breast CarcinomaHormone Receptor Positive Breast CarcinomaMetastatic 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

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 design

Treatments tested in this trial

  • Biospecimen Collection

Treatment groups

100 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov