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Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer

NCT03904173 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2300

Last updated 2025-08-08

No results posted yet for this study

Summary

The present project focuses on how to reduce both over- and under-treatment with adjuvant chemotherapy to a large number of breast cancer patients in Norway. A set of primary tumor prognostic factors can be analysed for potential achievement of this. Furthermore, multi-parameter tests, including detailed molecular analysis of the primary tumors might further improve the selection of patients among the lymph node negative. The study seeks to advance the development of personalised treatment of patients with early breast cancer without lymph node metastasis, by the evaluation of multi-parameter analysis as a means of identifying those patients who are likely to benefit from chemotherapy whilst sparing those who are unlikely to do so from an unnecessary and unpleasant treatment.

Conditions

Interventions

DIAGNOSTIC_TEST

Multi-parameter tests

Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50) risk of recurrence (ROR) analysis CE marked assay termed Prosigna™ using digital bar code technology (NanoString Technologies Inc.).

Sponsors & Collaborators

  • Klinbeforsk

    collaborator OTHER

  • Norwegian Cancer Society

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Bjørn Naume, MD PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2027-06-30
Completion
2043-12-31

Countries

  • Norway

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 NCT03904173 on ClinicalTrials.gov