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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT06388122
Status
Recruiting
Apply to this trial

Conditions

  • 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
  • HER2-negative Breast Cancer
  • Hormone Receptor Positive Breast Carcinoma
  • Hormone-receptor-positive Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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 Dates

Start date
Apr 30, 2024
Status verified
May 2026
Primary completion
Jun 15, 2031
Completion
Jun 15, 2031

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Group 1 (initiating 1st line CDK4/6 & endocrine therapy)
    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. Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.
  • Arm: Group 2 (initiating 2nd or later line of CDK4/6 with or without endocrine therapy)
    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. Blood will be drawn every 14 days starting from the first treatment cycle until the start of cycle 3; starting at cycle 3 blood will be drawn the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.
  • Arm: Group 3 (currently receiving 1st line CDK4/6 and endocrine therapy)
    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. Blood will be drawn on day 15 of the next cycle after enrollment and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.
  • Arm: Group 4 (initiating or currently receiving 1st or 2nd line endocrine therapy)
    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. Blood will be drawn at baseline or the first day of the treatment cycle and the first day of every cycle thereafter until progression. Optional blood draws will be taken with standard of care labs when starting next therapy.
  • Arm: 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.

Primary Outcome Measure

DiviTum®TKa assay as an early predictor of primary treatment resistance [ Time Frame: Every cycle (approximately 28 days) until disease progression up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials
[email protected]
855-776-0015
Pooja Advani, MBBS, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
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By specialty
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By research site
Mayo Clinic in Florida· Jacksonville, FL

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