MedTrace Logo

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

NCT04660435 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-02-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Thymidine kinase activity

DiviTum® assay determines the enzymatic activity of TK in serum samples

Sponsors & Collaborators

  • Clinical Research Technology S.r.l.

    collaborator INDUSTRY

  • Fondazione Sandro Pitigliani

    lead OTHER

Principal Investigators

  • Luca Malorni · Azienda USL Toscana Centro - Prato

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2025-12-01
Completion
2026-12-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04660435 on ClinicalTrials.gov