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RECRUITING
NCT03524430
NA

RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy

Sponsor: Rna Diagnostics Inc.

View on ClinicalTrials.gov

Summary

The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.

Official title: RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy (BREVITY / BREVITY-02 in Germany)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

801

Start Date

2018-04-26

Completion Date

2031-03-31

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

PROCEDURE

Core needle biopsy

1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy. If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation. If there is a change of drugs, the second biopsy (2 specimens) will be performed at \~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin.

Locations (7)

Siteman Cancer Center

St Louis, Missouri, United States

Sunnybrook Health Sciences Center

Toronto, Canada

Institut de Cancerologie de Strasbourg

Strasbourg, France

Universitätsklinikum Münster

Münster, Germany

SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

Cremona, Italy

NZOZ Neuromed

Lublin, Poland

Hospital U. 12 de Octubre

Madrid, Spain