Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: Thymidine kinase activity for Metastatic Breast Cancer

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.

Official registry: https://clinicaltrials.gov/study/NCT04660435 · Fondazione Sandro Pitigliani · enrollment listed as 150

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 150 people at Prato. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Identification and Monitoring of Resistance to First-line Treatment With CDK 4/6 Inhibitors in Combination With Aromatase Inhibitors in Patients With Metastatic Luminal Breast Cancer Through Non-invasive Biomarkers

Interventions: Thymidine kinase activity

Primary outcome (registry wording): Progression free survival

Who it is for (from inclusion criteria)

  • Women only
  • Women aged 18 years or older, with a diagnosis of metastatic breast cancer
  • ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis
  • The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo/adjuvant setting)
  • The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4/6 inhibitor per local clinical practice
  • The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable)
  • Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size
  • The patient agrees to provide blood samples. at the trial specified time points

Public study contact (from the registry)

Luca Malorni

+390574802523

luca.malorni@uslcentro.toscana.it

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT04660435 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04660435?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04660435?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary