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ACTIVE NOT RECRUITING
NCT03904173

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

Sponsor: Oslo University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2300

Start Date

2018-10-29

Completion Date

2043-12-31

Last Updated

2025-08-08

Healthy Volunteers

No

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.).

Locations (5)

Haukeland University Hospital

Bergen, Bergen, Norway

Drammen Hospital - Vestre Viken

Drammen, Buskerud, Norway

Østfold Hospital

Sarpsborg, Kalnes, Norway

Oslo University Hospital

Oslo, Oslo County, Norway

Telemark Hospital

Skien, Ulefossveien 55, Norway