To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer

Sponsor
Fondazione Sandro Pitigliani
Study ID
NCT04660435
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Thymidine kinase activity — DIAGNOSTIC_TEST
    DiviTum® assay determines the enzymatic activity of TK in serum samples

Study Details

This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor as per standard clinical practice. Blood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.

Key Dates

First listed
Dec 9, 2020
Start date
Sep 1, 2020
Status verified
Feb 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Women with ER+/Her2 negative metastatic breast cancer
    Patients with ER+/HER2-negative metastatic breast cancer candidate to first-line treatment with a CDK4/6 inhibitor and an aromatase inhibitor as per standard clinical practice

Primary Outcome Measure

Progression free survival [ Time Frame: 5 years ]

Central Contacts

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