A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients
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.
Inclusion Criteria
- * Females >= 18 years old * 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+ 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
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06388122.
Locations matching your search criteria
United States
Florida
Jacksonville
PRIMARY OBJECTIVES:
I. To quantify the value of the DiviTum registered trademark TKa assay as an early predictor of primary treatment resistance to CDK4/6 inhibitors in mBC.
II. To explore whether combining DiviTum registered trademark Tka-based patient classifications along with other patient characteristics could improve predictions of outcome.
OUTLINE: This is an observational study. Patients are assigned to 1 of 5 groups.
GROUP 1: Patients 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+ mBC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.
GROUP 2: Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.
GROUP 3: Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.
GROUP 4: Patients 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 undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.
GROUP 5: Patients 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 II or stage III adjuvant HR+ BC undergo blood sample collection and disease imaging throughout the study. Patients' medical records are also reviewed.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorPooja Prem Advani
- Primary IDMC240301
- Secondary IDsNCI-2024-03405, 23-009689
- ClinicalTrials.gov IDNCT06388122