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Personalised Disease Monitoring in Metastatic Breast Cancer

NCT04597580 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 97

Last updated 2025-12-02

No results posted yet for this study

Summary

Patients with metastatic breast cancer may respond well to treatment and metastases can remain stable for several years. Despite personalised medicine being increasingly used for diagnosis and treatment, follow-up still include radiological response evaluation every 3-4 months, which renders a significant number of 'unnecessary' exams for patients with long-term stable disease. Increasing evidence indicates that tumour markers such as circulating tumour DNA (ctDNA), thymidine kinase 1 (TK1) and cancer antigen 15-3 (CA15-3) may be useful for disease monitoring in the metastatic setting. However, algorithms that accurately define the time-points at which imaging can be foregone or reinstituted when progression is forecast, have not been developed. This study will measure ctDNA, TK1 and CA15-3 at all imaging time-points. The primary aim is to develop an algorithm based on these biomarkers, alone or in combination, that with sufficient specificity and sensitivity can advise whether a scan can be safely omitted at a specific time-point, for patients with MBC receiving first line therapy with AI plus cyclin dependent kinase 4/6 inhibitor (CDK4/6i). Additional samples will be stored such that novel biomarkers can also be tested in future. The cost-effectiveness of using the devised biomarker protocol will be evaluated.

Conditions

  • Breast Cancer Metastatic
  • Estrogen Receptor-positive Breast Cancer

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • The Christie NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Dr Sacha Howell, MD, PhD · University of Manchester and The Christie NHS Foundation Trust

  • Maria Ekholm, MD, PhD · University of Gothenburg and Region Jönköping

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2026-05-31
Completion
2030-01-31

Countries

  • Sweden
  • United Kingdom

Study Locations

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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 NCT04597580 on ClinicalTrials.gov